Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,EC
Pending LLM rewrite. Source: FDA_DEVICE Z-1423-2026.
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 Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
- 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) DYNJP2410
- UDI-DI: 10080196739691(each)
- 40080196739692(case)
- Lot Number: 30525050127
- 2) DYNJP2410
- Lot Number: 30525070161
- 3) DYNJP2410
- Lot Number: 30525070250
- 4) DYNJP2410
- Lot Number: 30525060147
- 5) DYNJP2410
- Lot Number: 30522030151
- 6) DYNJP2410
- Lot Number: 30522070033
- 7) DYNJP2410
- Lot Number: 30522080015
- 8) DYNJP2410
- Lot Number: 30522080067
- 9) DYNJP2410
- Lot Number: 30522090028
Distribution
Distributed nationwide across the United States.
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