Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOU
Pending LLM rewrite. Source: FDA_DEVICE Z-1425-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNJP1050UG
- UDI-DI: 10080196573509(each)
- 40080196573500(case)
- Lot Number: 72525030011
- 2) DYNJP1050UG
- Lot Number: 72525050004
- 3) DYNJP1050UG
- Lot Number: 72525100025
- 4) DYNJP1050UG
- Lot Number: 72525100068
- 5) DYNJP1050UG
- Lot Number: 72525020012
- 6) DYNJP1050UG
- Lot Number: 72525040038
- 7) DYNJP1050UG
- Lot Number: 72525060015
- 8) DYNJP1050UG
- Lot Number: 72525060041
- 9) DYNJP1050UG
- Lot Number: 72525080004
Distribution
Distributed nationwide across the United States.
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