The Recall Desk
HighFDA (Devices)·Z-0499-2023·Announced 2022-12-21

Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach

Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential breach of sterility due to incomplete outer bag sealing, which could expose patients to contamination during medical procedures, but no actual cases of harm have been documented.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE SAFETY PINS, SMALL 1" (Item No. 515-001) due to manufacturing defects. During production, the outer bags containing these pins may not have been completely sealed, potentially resulting in a breach of sterility in the medical and surgical procedure kits.

The affected product is identified by UDI/DI M7525150011 and Lot Number 22258491483. The product was distributed nationwide in the United States and in Canada.

The recalled product

Product
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Supplies
Hazard
  • sterility-breach
  • contamination-risk

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 (3)

  • UDI/DI (case) M7525150011
  • UDI/DI (kit)M7525150011
  • Serial/Lot Numbers: 22258491483

Distribution

Distributed nationwide across the United States.

Related recalls

Same category