CLASS I ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

BD Single-Lumen PowerPICC Catheters recalled by Bard Access Systems

Bard Access Systems is recalling BD Single-Lumen PowerPICC Catheters, distributed nationwide in the US. The recall was initiated on 11 Mar 2025 and the FDA has classified it as Class I.

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Lot, batch or date codesREF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027); CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027); 3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026); CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027); 3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027); 3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027); CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027); 9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027); CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025); 3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027); CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027); CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027); 3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025); 6174118/00801741139017/REHT2984(1/31/2026); 3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025); 3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025); 2174108/00801741138966/REHU3327(9/30/2025); 9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026); 3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026); 1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025); CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025); CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025); CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026); 1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026); CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025); CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025); 9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025); 1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025); CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025); 3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025); 3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025); CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025); 1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025); 1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025); CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025); CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025); CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025); CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025); CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025); 1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025); CK000867/00801741163272/REJN2377(5/31/2025); CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025); CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025); CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025); CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025); CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025); CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026); CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025); CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025); CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025); 1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025); 1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025); 1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025); CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025); CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025); CK000411/00801741096303/REJN3872(5/31/2025); CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025); 1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025); CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025); CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025); CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025); CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025); CK000619A/00801741132001/REJN3985(6/30/2025); CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025); 3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025); 1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025); 9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025); CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025); CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026); CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025); CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025); CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025); CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025); CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025); CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026); CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025); CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025); CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025); CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025); CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025); CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025); CK000266A/00801741185014/REJP2755(7/31/2025); 1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025); 3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025); CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027); 1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025); 3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025); CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025); 1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025); CK000736/00801741139499/REJQ1480(6/30/2025); CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026); 9194108/00801741028595/REJR0580(9/30/2025); 1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025); CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025); CK000609A/00801741222504/REJR1654(6/30/2025); 9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025); CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025); CK000077D/00801741139598/REJR2231(9/30/2025); CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025); CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025); CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025); CK000870A/00801741184246/REJS3569(10/31/2025); CK000443C/00801741226557/REJT0880(10/31/2025); CK000668B/00801741228674/REJT1820(10/31/2025); CK000784/00801741189012/REJU0379(9/30/2025)
Quantity recalled718,461

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1507-2025
FDA event ID
96426
Recalling firm
Bard Access Systems, Salt Lake City, UT
Classification
Class I
Status
Ongoing
Recall initiated
11 Mar 2025
FDA classified
16 Apr 2025
Reported
23 Apr 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

11 Mar 2025Recall initiated by company
16 Apr 2025Classified by FDA+36 days
23 Apr 2025Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

Where it was distributed

Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts

Questions about this recall

Why was it recalled?

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

Which lots are affected?

REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027); CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027); 3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026); CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027); 3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027); 3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027); CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027); 9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027); CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025); 3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027); CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027); CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027); 3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025); 6174118/00801741139017/REHT2984(1/31/2026); 3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025); 3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025); 2174108/00801741138966/REHU3327(9/30/2025); 9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026); 3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026); 1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025); CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025); CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025); CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026); 1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026); CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025); CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025); 9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025); 1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025); CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025); 3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025); 3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025); CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025); 1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025); 1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025); CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025); CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025); CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025); CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025); CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025); 1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025); CK000867/00801741163272/REJN2377(5/31/2025); CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025); CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025); CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025); CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025); CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025); CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026); CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025); CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025); CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025); 1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025); 1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025); 1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025); CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025); CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025); CK000411/00801741096303/REJN3872(5/31/2025); CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025); 1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025); CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025); CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025); CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025); CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025); CK000619A/00801741132001/REJN3985(6/30/2025); CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025); 3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025); 1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025); 9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025); CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025); CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026); CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025); CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025); CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025); CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025); CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025); CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026); CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025); CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025); CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025); CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025); CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025); CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025); CK000266A/00801741185014/REJP2755(7/31/2025); 1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025); 3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025); CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027); 1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025); 3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025); CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025); 1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025); CK000736/00801741139499/REJQ1480(6/30/2025); CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026); 9194108/00801741028595/REJR0580(9/30/2025); 1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025); CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025); CK000609A/00801741222504/REJR1654(6/30/2025); 9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025); CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025); CK000077D/00801741139598/REJR2231(9/30/2025); CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025); CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025); CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025); CK000870A/00801741184246/REJS3569(10/31/2025); CK000443C/00801741226557/REJT0880(10/31/2025); CK000668B/00801741228674/REJT1820(10/31/2025); CK000784/00801741189012/REJU0379(9/30/2025)

Where was it sold?

Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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