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Integra®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model MCLS37 · UDI-DI 10381780106951

MMO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Integra® Sataloff Instrument Tray for Picks, Handles and Needles, 50cm L*23cm W*4.2cm D

Recalls

Date	Firm	Reason
2026-03-19	Medline Industries, LP	During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-11-21	MEDLINE INDUSTRIES, LP - Northfield	Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2022-11-17	MEDLINE INDUSTRIES, LP - Northfield	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
2013-07-09	Medtronic Xomed, Inc.	The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACU

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.