Medline Surgical Packs recalled due to sterilization equipment calibration issues
Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The source text explicitly states that all products were exposed to validated sterilization cycles and the hazard is a potential impact to sterility assurance, not confirmed failure. The hazard is precautionary and theoretical rather than an established safety failure.
Plain-English summary
Medline Industries, LP is recalling Medline Surgical Packs, specifically two models: PACK,UNIVERSAL,ULTRAGARD,5/CS (Model Number DYNJP1050UG) and PACK,SHOULDER,DRAPE,POUCH,10/CS (Model Number DYNJP8401). The recall affects approximately 193,157 units distributed nationwide in the United States and worldwide.
The company has identified calibration issues related to the equipment used to sterilize and package these medical devices. While all recalled products were exposed to validated sterilization and packaging cycles, the identified calibration problems have the potential to impact the sterility assurance level (SAL) of the products.
Healthcare facilities and individuals who have received these surgical packs should stop using the affected lot numbers immediately. Contact Medline Industries, LP for instructions on replacement or return of the recalled products. A complete list of affected lot numbers is available from the FDA.
This is an FDA Class II recall. Consumers with questions should contact Medline Industries or consult the FDA's recall notice.
The recalled product
- Product
- Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
- Manufacturer
- Medline Industries, LP
- Hazard
- sterility-assurance
- sterilization-failure
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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