Reported May 13, 2026 · Ongoing
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2)…
Medline Industries, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline Surgical Packs1) PACK,UNIVERSAL,ULTRAGARD,5/CS
- Model NumberDYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS
- Model NumberDYNJP8401
- Lot codes and dates
78 of 78 products
Products covered by this recall # Barcodes Product as published 1 1008019657350940080196573500Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 2 1008019657350940080196573500Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 3 1008019657350940080196573500Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 4 1008019657350940080196573500Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 5 1008019657350940080196573500Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 6 1008019657350940080196573500Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 7 1008019657350940080196573500Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 8 1008019657350940080196573500Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 9 1008019657350940080196573500Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 10 1008019657350940080196573500Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 11 1008019657350940080196573500Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 12 1008019657350940080196573500Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 13 1008019657350940080196573500Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 14 1008019657350940080196573500Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 15 1008019657350940080196573500Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 16 1008019657350940080196573500Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 17 1008019657350940080196573500Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 18 1008019657350940080196573500Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 19 1008019657350940080196573500Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) 20 1008019657350940080196573500Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case) - Amount recalled
- 193157 units
This recall covers 42 products
The agency filed one notice per product. You are reading one of them; the other 41 are below.
29 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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