CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
Medline Convenience Kits: CVC PACK recalled by Medline Industries
Medline Industries is recalling Medline Convenience Kits: CVC PACK, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 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-2102-2026
- FDA event ID
- 98642
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2026
- FDA classified
- 7 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 7 May 2026 | Classified by FDA | +120 days |
| 13 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 6) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 7) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 8) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 9) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 10) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 11) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 12) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 16) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 17) CHEST TUBE SUPPLIES, Model Number: DYKM2131
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Which lots are affected?
1) CVI4500A, UDI-DI: 10653160327646(each), 653160327649(case), Lot Number: 2020121550; 2) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 3) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 4) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 5) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 6) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 7) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 8) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 9) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 10) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 11) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 12) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 13) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 14) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 15) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 16) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 17) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 18) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 19) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 20) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 21) DYKM1781A, UDI-DI: 10653160352730(each), 653160352733(case), Lot Number: 2024092390; 22) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 23) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 24) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 25) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024041790; 26) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024061890; 27) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024072390; 28) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2024093090; 29) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2025010890; 30) DYKM1796A, UDI-DI: 10653160354888(each), 653160354881(case), Lot Number: 2025020690; 31) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024011790; 32) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024062890; 33) DYKM1801B, UDI-DI: 10653160360421(each), 653160360424(case), Lot Number: 2024100790; 34) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 35) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 36) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 37) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 38) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 39) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 40) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 41) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 42) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 43) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 44) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 45) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2023063090; 46) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2023120890; 47) DYKM1977B, UDI-DI: 10653160360797(each), 653160360790(case), Lot Number: 2024091290; 48) DYKM2131, UDI-DI: 10195327058715(each), 40195327058716(case), Lot Number: 23ALA008
Where was it sold?
Worldwide - US Nationwide distribution.
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
35 other products · FDA event 98642This product is part of a recall event; the main page for the event is See RES for complete list recalled by Medline Industries.
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|---|---|---|---|---|---|
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