The Recall Desk
Severity pendingFDA (Devices)·Z-1424-2026·Announced 2026-02-25

Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SET

Pending LLM rewrite. Source: FDA_DEVICE Z-1424-2026.

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 Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOW
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) DYNJP2001
  • UDI-DI: 10080196073641(each)
  • 40080196073642(case)
  • Lot Number: 30525050165
  • 2) DYNJP2001
  • Lot Number: 30525070175
  • 3) DYNJP2001
  • Lot Number: 30525070223
  • 4) DYNJP2001
  • Lot Number: 30525100047
  • 5) DYNJP2001
  • Lot Number: 30525100144
  • 6) DYNJP2001
  • Lot Number: 30525100377
  • 7) DYNJP2001
  • Lot Number: 30525020078
  • 8) DYNJP2001
  • Lot Number: 30525040212
  • 9) DYNJP2001
  • Lot Number: 30525060247

Distribution

Distributed nationwide across the United States.

Related recalls

Same category