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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 193,157
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.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · sterility assurance
See all →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
Similar recalls
- HighUniversal and shoulder packs recalled over sterilization calibration issues
FDA (Devices) · 2026-02-25
- HighDrape packs recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighSurgical drapes recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighChoice drape packs recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- SevereMedline Burn Care Kits Recalled Over Sterilization Calibration Issues
FDA (Devices) · 2026-02-25
- SevereMedline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration
FDA (Devices) · 2026-02-25