The Recall Desk
HighFDA (Devices)·Z-0522-2023·Announced 2022-12-21

Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing

Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.

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: FDA Class II medical device recall involving potential sterility compromise on surgical procedure kits. Although no illnesses have been reported, the risk-of-harm from compromised sterility in surgical instruments justifies a High rating.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling 144 units of the Henry Schein Loop Recorder Pack surgical procedure trays (Item No. 570-2891, Lot No. 22252491813). The product was distributed nationwide in the United States and Canada.

The outer bag on these trays may be incompletely sealed due to the manufacturing process used. An incomplete seal can compromise the sterility of the kit, which is critical for safe use in surgical and medical procedures.

Users should immediately stop using the recalled product. Healthcare facilities and consumers with the affected lot should contact Stradis Medical for replacement or return instructions. No illnesses or injuries related to this issue have been reported to date.

The recalled product

Product
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Trays
Hazard
  • sterility-breach
  • contamination

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) H65857028911
  • UDI/DI (kit)M75257028910
  • Serial/Lot Numbers: 22252491813

Distribution

Distributed nationwide across the United States.

Related recalls

Same category