CLASS II ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report
Sterile Procedural Trays, labeled as the following recalled
Medline Industries LP - Northfield is recalling Sterile Procedural Trays, labeled as the following: a. Gyn-uro Lapscp Cds-lf b. Robotic, distributed nationwide in the US. The recall was initiated on 17 Nov 2022 and the FDA has classified it as Class II.
Check your package
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-1091-2023
- FDA event ID
- 91386
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Nov 2022
- FDA classified
- 6 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Nov 2022 | Recall initiated by company | |
| 6 Feb 2023 | Classified by FDA | +81 days |
| 15 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Questions about this recall
Why was it recalled?
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Which lots are affected?
a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255; b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176; c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989; d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743; e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054; f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586; g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498; h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848; i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358; j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299; k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254; l. GYN LAPAROSCOPY CDS-LF, Item Number: CDS984536J, Case UDI/GTIN: 40193489831345, Unit UDI/GTIN: 10193489831344, Lot Number: 22IDB843; m. GYN LAPAROSCOPY CDS UCC-LF, Item Number: CDS984684D, Case UDI/GTIN: 40193489571364, Unit UDI/GTIN: 10193489571363, Lot Number: 22JBR850,22JBE881,22IBV318; n. DAY SURG GYN LAP CDS, Item Number: CDS984996K, Case UDI/GTIN: 40195327175772, Unit UDI/GTIN: 10195327175771, Lot Number: 22JBD508; o. GYN LAPAROSCOPY CDS, Item Number: CDS985217J, Case UDI/GTIN: 40195327110841, Unit UDI/GTIN: 10195327110840, Lot Number: 22KBC728,22IBA646; p. DAVINCI HYSTERECTOMY CDS, Item Number: CDS985344D, Case UDI/GTIN: 40193489905527, Unit UDI/GTIN: 10193489905526, Lot Number: 22IBR928,22IBS195; q. GYN LAP/ROBOTIC, Item Number: CDS985466G, Case UDI/GTIN: 40195327043118, Unit UDI/GTIN: 10195327043117, Lot Number: 22JDB080; r. DAVINCI PACK-LF, Item Number: DYNJ0046535D, Case UDI/GTIN: 40195327095667, Unit UDI/GTIN: 10195327095666, Lot Number: 22JMH534; s. DAVINCI PACK-LF, Item Number: DYNJ0161960F, Case UDI/GTIN: 40195327171521, Unit UDI/GTIN: 10195327171520, Lot Number: 22IDB492,22IDA146; t. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ01910K, Case UDI/GTIN: 40193489962803, Unit UDI/GTIN: 10193489962802, Lot Number: 22IBU972; u. ROBOTIC PACK, Item Number: DYNJ02457K, Case UDI/GTIN: 40195327108923, Unit UDI/GTIN: 10195327108922, Lot Number: 22JMG295; v. GYN LAP - UNIV, Item Number: DYNJ0375503L, Case UDI/GTIN: 40193489943215, Unit UDI/GTIN: 10193489943214, Lot Number: 22JBP432; w. BASIC LAVH PACK, Item Number: DYNJ0378714G, Case UDI/GTIN: 40889942435266, Unit UDI/GTIN: 10889942435265, Lot Number: 22IBI287; x. GYN/LAPAROSCOPY PACK-LF, Item Number: DYNJ0395118K, Case UDI/GTIN: 40195327063895, Unit UDI/GTIN: 10195327063894, Lot Number: 22JBS258; y. LAPAROSCOPIC GYN PACK-LF, Item Number: DYNJ04718T, Case UDI/GTIN: 40193489444873, Unit UDI/GTIN: 10193489444872, Lot Number: 22JMC979; z. DAVINCI PACK-LF, Item Number: DYNJ0556546D, Case UDI/GTIN: 40195327271726, Unit UDI/GTIN: 10195327271725, Lot Number: 22JMI211; aa. SCC GYN LAPAROSCOPY PACK, Item Number: DYNJ16604R, Case UDI/GTIN: 40195327218615, Unit UDI/GTIN: 10195327218614, Lot Number: 22JMB584; bb. URO GYN PACK-LF, Item Number: DYNJ17454M, Case UDI/GTIN: 40193489776028, Unit UDI/GTIN: 10193489776027, Lot Number: 22IBN968,22HBK091; cc. GYN LAPAROSCOPY PACK, Item Number: DYNJ30301D, Case UDI/GTIN: 40889942764953, Unit UDI/GTIN: 10889942764952, Lot Number: 22JBX986; dd. TUBAL PACK, Item Number: DYNJ30481G, Case UDI/GTIN: 40193489912891, Unit UDI/GTIN: 10193489912890, Lot Number: 22JMA315; ee. GYN LAP PACK-LF, Item Number: DYNJ32754M, Case UDI/GTIN: 40193489588980, Unit UDI/GTIN: 10193489588989, Lot Number: 22IMD300,22IMD302; ff. LAVH PACK, Item Number: DYNJ36508B, Case UDI/GTIN: 40889942715764, Unit UDI/GTIN: 10889942715763, Lot Number: 22JBJ622; gg. GYN LAPAROSCOPY-LF, Item Number: DYNJ36713B, Case UDI/GTIN: 40195327148035, Unit UDI/GTIN: 10195327148034, Lot Number: 22JBG940,22HBR656; hh. LAVH PACK, Item Number: DYNJ37785B, Case UDI/GTIN: 40888277792280, Unit UDI/GTIN: 10888277792289, Lot Number: 22IBK833; ii. PK-GYN-LAPAROSCOPY, Item Number: DYNJ42386D, Case UDI/GTIN: 40195327253340, Unit UDI/GTIN: 10195327253349, Lot Number: 22JMH924; jj. MAJOR LAP PACK 2-LF, Item Number: DYNJ42635D, Case UDI/GTIN: 40193489919425, Unit UDI/GTIN: 10193489919424, Lot Number: 22JBW532,22JBH135,22IBD371; kk. TUBAL PACK, Item Number: DYNJ42636, Case UDI/GTIN: 40888277003577, Unit UDI/GTIN: 10888277003576, Lot Number: 22KBA571; ll. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ42838B, Case UDI/GTIN: 40193489880374, Unit UDI/GTIN: 10193489880373, Lot Number: 22IBT573,22HBY144; mm. PK, ROBOTICS-GYN, Item Number: DYNJ43715B, Case UDI/GTIN: 40193489322911, Unit UDI/GTIN: 10193489322910, Lot Number: 22IBU770; nn. SVMMC GEN ROBOTIC PACK, Item Number: DYNJ43770L, Case UDI/GTIN: 40193489989992, Unit UDI/GTIN: 10193489989991, Lot Number: 22JBT938,22IBC524; oo. SVMMC GYN ROBOTIC PACK, Item Number: DYNJ43782K, Case UDI/GTIN: 40193489989893, Unit UDI/GTIN: 10193489989892, Lot Number: 22JBM498,22IBD372; pp. PACK, GYN-D&C, Item Number: DYNJ43931C, Case UDI/GTIN: 40193489431606, Unit UDI/GTIN: 10193489431605, Lot Number: 22JMD510; qq. DA VINCI PROSTATE/COLPOPEXY, Item Number: DYNJ44864S, Case UDI/GTIN: 40195327127627, Unit UDI/GTIN: 10195327127626, Lot Number: 22HBY159; rr. ROBOT PACK, Item Number: DYNJ45184F, Case UDI/GTIN: 40195327191475, Unit UDI/GTIN: 10195327191474, Lot Number: 22JBD483; ss. PK, GYN-LAPAROSCOPY, Item Number: DYNJ46271A, Case UDI/GTIN: 40193489338295, Unit UDI/GTIN: 10193489338294, Lot Number: 22IBS007; tt. LAPAROSCOPIC GYN PACK, Item Number: DYNJ47274L, Case UDI/GTIN: 40195327263943, Unit UDI/GTIN: 10195327263942, Lot Number: 22JMI249,22JMA188; uu. DAVINCI PACK-RFD, Item Number: DYNJ47762M, Case UDI/GTIN: 40195327105434, Unit UDI/GTIN: 10195327105433, Lot Number: 22JME004,22JMD998; vv. GYN ROBOTIC PACK, Item Number: DYNJ47766Q, Case UDI/GTIN: 40195327270002, Unit UDI/GTIN: 10195327270001, Lot Number: 22JDB952; ww. LAVH PACK, Item Number: DYNJ48599, Case UDI/GTIN: 40888277915115, Unit UDI/GTIN: 10888277915114, Lot Number: 22JBC120; xx. ST. ANNE'S MULTI PORT PACK, Item Number: DYNJ48638G, Case UDI/GTIN: 40195327109159, Unit UDI/GTIN: 10195327109158, Lot Number: 22IBP249; yy. LAVH PACK, Item Number: DYNJ49353, Case UDI/GTIN: 40888277846761, Unit UDI/GTIN: 10888277846760, Lot Number: 22IBN984; zz. SOUTH SC RFT GYN LAP PACK, Item Number: DYNJ50840A, Case UDI/GTIN: 40889942221371, Unit UDI/GTIN: 10889942221370, Lot Number: 22JMI259,22JMC606; aaa. GYN LAPAROSCOPY PACK, Item Number: DYNJ51102B, Case UDI/GTIN: 40193489985338, Unit UDI/GTIN: 10193489985337, Lot Number: 22JDB774; bbb. LITHOTOMY PENILE PACK, Item Number: DYNJ51161C, Case UDI/GTIN: 40889942493792, Unit UDI/GTIN: 10889942493791, Lot Number: 22JBH136,22HBR181; ccc. DAVINCI GENERAL PACK, Item Number: DYNJ51399J, Case UDI/GTIN: 40193489984492, Unit UDI/GTIN: 10193489984491, Lot Number: 22HDA632; ddd. DAVINCI GYN PACK, Item Number: DYNJ51400J, Case UDI/GTIN: 40193489984508, Unit UDI/GTIN: 10193489984507, Lot Number: 22IDA309; eee. DAVINCI GYN PACK, Item Number: DYNJ51400K, Case UDI/GTIN: 40195327277605, Unit UDI/GTIN: 10195327277604, Lot Number: 22JDB871; fff. ROBOTIC PROSTATE PACK, Item Number: DYNJ52085M, Case UDI/GTIN: 40195327210374, Unit UDI/GTIN: 10195327210373, Lot Number: 22JDB086; ggg. GYN ROBOTIC PACK-LF, Item Number: DYNJ52432J, Case UDI/GTIN: 40195327073979, Unit UDI/GTIN: 10195327073978, Lot Number: 22JDB177; hhh. SCRIPPS SW ROBOTIC PACK, Item Number: DYNJ52564D, Case UDI/GTIN: 40195327176427, Unit UDI/GTIN: 10195327176426, Lot Number: 22HMF120,22HME681,22HME682,22FMB534; iii. GYN LITHOTOMY PACK, Item Number: DYNJ53327A, Case UDI/GTIN: 40889942592938, Unit UDI/GTIN: 10889942592937, Lot Number: 22JMG479; jjj. GYN LAPAROSCOPY PACK, Item Number: DYNJ53631G, Case UDI/GTIN: 40195327145430, Unit UDI/GTIN: 10195327145439, Lot Number: 22IBT104; kkk. DEACONESS PELVIC LAP PACK, Item Number: DYNJ53820A, Case UDI/GTIN: 40195327132188, Unit UDI/GTIN: 10195327132187, Lot Number: 22IBL549; lll. WOMENS ROBOT PACK, Item Number: DYNJ53857A, Case UDI/GTIN: 40193489497664, Unit UDI/GTIN: 10193489497663, Lot Number: 22IBD203; mmm. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ54367, Case UDI/GTIN: 40889942478881, Unit UDI/GTIN: 10889942478880, Lot Number: 22JMG368; nnn. MAJOR GYN PACK, Item Number: DYNJ55693I, Case UDI/GTIN: 40193489847575, Unit UDI/GTIN: 10193489847574, Lot Number: 22IBL365; ooo. GYN LAPAROSCOPY PACK, Item Number: DYNJ56441, Case UDI/GTIN: 40889942646426, Unit UDI/GTIN: 10889942646425, Lot Number: 22HBH543; ppp. TUBAL PACK-LF, Item Number: DYNJ56657, Case UDI/GTIN: 40889942666271, Unit UDI/GTIN: 10889942666270, Lot Number: 22IMB764; qqq. PK, GYN-LAPAROSCOPY, Item Number: DYNJ57609B, Case UDI/GTIN: 40195327244577, Unit UDI/GTIN: 10195327244576, Lot Number: 22IMI129; rrr. LAVH PACK, Item Number: DYNJ57740, Case UDI/GTIN: 40889942773689, Unit UDI/GTIN: 10889942773688, Lot Number: 22IBL578; sss. LAPAROTOMY PACK, Item Number: DYNJ59079D, Case UDI/GTIN: 40195327200252, Unit UDI/GTIN: 10195327200251, Lot Number: 22JBC271,22HBF903; ttt. URO/GEN ROBOTIC PACK, Item Number: DYNJ60803J, Case UDI/GTIN: 40195327138821, Unit UDI/GTIN: 10195327138820, Lot Number: 22KDA153,22IDA962; uuu. BASIC ROBOTIC PACK, Item Number: DYNJ62750B, Case UDI/GTIN: 40193489975858, Unit UDI/GTIN: 10193489975857, Lot Number: 22KBC719,22HBV643,22HBI644; vvv. LAPAROSCOPIC GYN PACK, Item Number: DYNJ62831B, Case UDI/GTIN: 40193489887274, Unit UDI/GTIN: 10193489887273, Lot Number: 22JDC183; www. PK, ROBOTICS-GYN, Item Number: DYNJ63445B, Case UDI/GTIN: 40193489318396, Unit UDI/GTIN: 10193489318395, Lot Number: 22JBC766,22IBI894; xxx. PQ CHG CTRY GYN LAP PK, Item Number: DYNJ64039A, Case UDI/GTIN: 40195327263585, Unit UDI/GTIN: 10195327263584, Lot Number: 22JMC821; yyy. GYN DAVINCI PACK, Item Number: DYNJ64266, Case UDI/GTIN: 40193489795517, Unit UDI/GTIN: 10193489795516, Lot Number: 22JDB068; zzz. ROBOT GYN SHARED, Item Number: DYNJ64793B, Case UDI/GTIN: 40195327217915, Unit UDI/GTIN: 10195327217914, Lot Number: 22JDA845,22HDC106; aaaa. PK, ROBOTICS-GEN, Item Number: DYNJ65193A, Case UDI/GTIN: 40195327244584, Unit UDI/GTIN: 10195327244583, Lot Number: 22IMH017; bbbb. DAVINCI PACK, Item Number: DYNJ66298D, Case UDI/GTIN: 40195327095896, Unit UDI/GTIN: 10195327095895, Lot Number: 22JBQ463; cccc. ROBOTIC GYN PACK, Item Number: DYNJ68688A, Case UDI/GTIN: 40195327095872, Unit UDI/GTIN: 10195327095871, Lot Number: 22JBK548; dddd. ROBOTICS PACK, Item Number: DYNJ69869, Case UDI/GTIN: 40193489992244, Unit UDI/GTIN: 10193489992243, Lot Number: 22HBY203; eeee. PK- ROBOTICS, Item Number: DYNJ69869A, Case UDI/GTIN: 40195327252558, Unit UDI/GTIN: 10195327252557, Lot Number: 22JBL867; ffff. GYN LAPAROSCOPY, Item Number: DYNJ69893A, Case UDI/GTIN: 40195327235018, Unit UDI/GTIN: 10195327235017, Lot Number: 22JBC621,22IBI272; gggg. GU ROBOTIC PACK, Item Number: DYNJ82464, Case UDI/GTIN: 40195327197187, Unit UDI/GTIN: 10195327197186, Lot Number: 22HBJ903; hhhh. GYN PACK, Item Number: DYNJ82488, Case UDI/GTIN: 40195327197446, Unit UDI/GTIN: 10195327197445, Lot Number: 22HBJ906; iiii. BASIC GYN PACK, Item Number: DYNJ82505, Case UDI/GTIN: 40195327198306, Unit UDI/GTIN: 10195327198305, Lot Number: 22HBI366; jjjj. BWH GYN ROBOTICS PACK, Item Number: DYNJ82559, Case UDI/GTIN: 40195327197958, Unit UDI/GTIN: 10195327197957, Lot Number: 22HBQ038; kkkk. BWH GU ROBOTICS PACK, Item Number: DYNJ82560, Case UDI/GTIN: 40195327197965, Unit UDI/GTIN: 10195327197964, Lot Number: 22HBQ039; llll. URO GYN PACK, Item Number: DYNJ82621, Case UDI/GTIN: 40195327199075, Unit UDI/GTIN: 10195327199074, Lot Number: 22HBT063; mmmm. GYN LAP PACK, Item Number: DYNJ82624, Case UDI/GTIN: 40195327199105, Unit UDI/GTIN: 10195327199104, Lot Number: 22HBN265; nnnn. GYN LAPAROSCOPY, Item Number: DYNJ900262, Case UDI/GTIN: 40888277206473, Unit UDI/GTIN: 10888277206472, Lot Number: 22JBR395,22IBT179; oooo. ROBOTIC, Item Number: DYNJ900524K, Case UDI/GTIN: 40193489995290, Unit UDI/GTIN: 10193489995299, Lot Number: 22JDB906,22IDA179; pppp. GYN ROBOTIC, Item Number: DYNJ901046G, Case UDI/GTIN: 40193489820967, Unit UDI/GTIN: 10193489820966, Lot Number: 22JBW050; qqqq. CV ROBOTIC SET UP, Item Number: DYNJ901082C, Case UDI/GTIN: 40193489927659, Unit UDI/GTIN: 10193489927658, Lot Number: 22JBD190,22IBV320; rrrr. GYN LAPAROSCOPY, Item Number: DYNJ901208C, Case UDI/GTIN: 40193489313636, Unit UDI/GTIN: 10193489313635, Lot Number: 22KBF260; ssss. ROBOTIC LAVH, Item Number: DYNJ901281F, Case UDI/GTIN: 40193489961158, Unit UDI/GTIN: 10193489961157, Lot Number: 22IBQ970; tttt. ROBOTIC LAP CHOLE, Item Number: DYNJ901282I, Case UDI/GTIN: 40193489961165, Unit UDI/GTIN: 10193489961164, Lot Number: 22JBI004,22IBT626; uuuu. GYN LAPAROSCOPY, Item Number: DYNJ901370J, Case UDI/GTIN: 40195327245451, Unit UDI/GTIN: 10195327245450, Lot Number: 22JBR464; vvvv. GYN LAPAROSCOPY, Item Number: DYNJ901774F, Case UDI/GTIN: 40193489945677, Unit UDI/GTIN: 10193489945676, Lot Number: 22JBX890,22JBA940; wwww. GYN ROBOTIC, Item Number: DYNJ901796K, Case UDI/GTIN: 40193489979702, Unit UDI/GTIN: 10193489979701, Lot Number: 22IBD418; xxxx. GYN ENDOSCOPY-LF, Item Number: DYNJ901812J, Case UDI/GTIN: 40193489814164, Unit UDI/GTIN: 10193489814163, Lot Number: 22JDB621,22JDA090; yyyy. GYN LAPAROSCOPY, Item Number: DYNJ902371I, Case UDI/GTIN: 40195327223459, Unit UDI/GTIN: 10195327223458, Lot Number: 22KBH351; zzzz. LAP ROBOTIC, Item Number: DYNJ902384J, Case UDI/GTIN: 40193489978088, Unit UDI/GTIN: 10193489978087, Lot Number: 22JBD080; aaaaa. TUBAL LIGATION CDS, Item Number: DYNJ902721D, Case UDI/GTIN: 40193489907927, Unit UDI/GTIN: 10193489907926, Lot Number: 22JBW509; bbbbb. GYN LAPAROSCOPY, Item Number: DYNJ903422F, Case UDI/GTIN: 40193489700320, Unit UDI/GTIN: 10193489700329, Lot Number: 22KBF386,22JBN707; ccccc. ROBOTIC GYN & GU, Item Number: DYNJ903459F, Case UDI/GTIN: 40195327200375, Unit UDI/GTIN: 10195327200374, Lot Number: 22IBD806,22IBE664; ddddd. ROBOTIC, Item Number: DYNJ903485G, Case UDI/GTIN: 40195327172528, Unit UDI/GTIN: 10195327172527, Lot Number: 22JDB549; eeeee. GYN LAPAROSCOPY, Item Number: DYNJ903812C, Case UDI/GTIN: 40193489274111, Unit UDI/GTIN: 10193489274110, Lot Number: 22JBH771,22JBH772; fffff. ROBOT GYN, Item Number: DYNJ904709F, Case UDI/GTIN: 40195327159963, Unit UDI/GTIN: 10195327159962, Lot Number: 22JBW052; ggggg. GYN LAPAROSCOPY, Item Number: DYNJ904713A, Case UDI/GTIN: 40193489674300, Unit UDI/GTIN: 10193489674309, Lot Number: 22JBX929,22JBE278; hhhhh. FHWC ROBOTIC, Item Number: DYNJ905195F, Case UDI/GTIN: 40195327216482, Unit UDI/GTIN: 10195327216481, Lot Number: 22IBQ982; iiiii. GYN LAPAROSCOPY, Item Number: DYNJ905797B, Case UDI/GTIN: 40193489800815, Unit UDI/GTIN: 10193489800814, Lot Number: 22JMC890; jjjjj. GYN LAPAROSCOPY, Item Number: DYNJ906120C, Case UDI/GTIN: 40195327223701, Unit UDI/GTIN: 10195327223700, Lot Number: 22JDB406; kkkkk. ROBOTIC, Item Number: DYNJ906508B, Case UDI/GTIN: 40195327026524, Unit UDI/GTIN: 10195327026523, Lot Number: 22JMD368; lllll. PELVISCOPY, Item Number: DYNJ906536A, Case UDI/GTIN: 40193489815055, Unit UDI/GTIN: 10193489815054, Lot Number: 22KBB847,22KBA201; mmmmm. GENERAL ROBOT-TCN, Item Number: DYNJ906552D, Case UDI/GTIN: 40195327144860, Unit UDI/GTIN: 10195327144869, Lot Number: 22KBH170,22IBU705,22IBA547; nnnnn. ROBOTICS, Item Number: DYNJ906683B, Case UDI/GTIN: 40195327225705, Unit UDI/GTIN: 10195327225704, Lot Number: 22JBR762; ooooo. CVOR ROBOT, Item Number: DYNJ906692A, Case UDI/GTIN: 40195327061532, Unit UDI/GTIN: 10195327061531, Lot Number: 22IBT518; ppppp. GU-GEN ROBOTIC, Item Number: DYNJ906876C, Case UDI/GTIN: 40195327110681, Unit UDI/GTIN: 10195327110680, Lot Number: 22JBD052,22JBB138; qqqqq. FLOYD LAP GYN, Item Number: DYNJ906931C, Case UDI/GTIN: 40193489921299, Unit UDI/GTIN: 10193489921298, Lot Number: 22KBE721,22KBB791,22JBA952; rrrrr. GYN ROBOTIC, Item Number: DYNJ907492D, Case UDI/GTIN: 40195327247462, Unit UDI/GTIN: 10195327247461, Lot Number: 22JBA125; sssss. GYN LAPAROSCOPY CDS, Item Number: DYNJ907841A, Case UDI/GTIN: 40195327018321, Unit UDI/GTIN: 10195327018320, Lot Number: 22JBO683; ttttt. LAP TUBAL, Item Number: DYNJ907883A, Case UDI/GTIN: 40195327019151, Unit UDI/GTIN: 10195327019150, Lot Number: 22KBH354,22JBO108; uuuuu. DAVINCI GENERAL, Item Number: DYNJ908477A, Case UDI/GTIN: 40195327191925, Unit UDI/GTIN: 10195327191924, Lot Number: 22JMG912,22JMF336; vvvvv. DAVINCI LOW ANTERIOR RESECTION, Item Number: DYNJ908479A, Case UDI/GTIN: 40195327192021, Unit UDI/GTIN: 10195327192020, Lot Number: 22JBQ504; wwwww. GYN, Item Number: DYNJ908504A, Case UDI/GTIN: 40195327251292, Unit UDI/GTIN: 10195327251291, Lot Number: 22JBR467,22JBR815; xxxxx. PELVISCOPY PACK, Item Number: DYNJT2136M, Case UDI/GTIN: 40195327109067, Unit UDI/GTIN: 10195327109066, Lot Number: 22IME712; yyyyy. GYN LAPAROSCOPY STD PACK-LF, Item Number: PHS38678001B, Case UDI/GTIN: 40193489636612, Unit UDI/GTIN: 10193489636611, Lot Number: 22HBX127; zzzzz. LAP GYN PACK-LF, Item Number: PHS988229I, Case UDI/GTIN: 40193489766036, Unit UDI/GTIN: 10193489766035, Lot Number: 22JMG416,22IME802
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
34 other products · FDA event 91386This product is part of a recall event; the main page for the event is Sterile Procedural Trays, labeled as the following recalled.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |