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LID 2

Bradshaw Medical, Inc. · Model MRS-116-02-01 · UDI-DI 00810019931925

FSM

510(k) clearances

2,231

Adverse events (2 deaths)

Recalls

874

Facilities

Description

The lid is designed to fit securely over the base, creating a sealed environment. It features a filter system, typically a perforated plate with a disposable filter, that allows sterilizing agents (like steam or gas) to enter the container and reach the instruments. After the sterilization cycle is complete, this filter system prevents microorganisms from entering, thereby maintaining the sterility of the contents until the container is opened for use.

Recalls

Date	Firm	Reason
2025-07-18	Encore Medical, LP	Their is a potential that the reamer may kick or bind up during or immediately prior to use.
2024-06-11	Medical Action Industries, Inc. 306	The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa
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
2023-11-15	MEDLINE INDUSTRIES, LP - Northfield	Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile
2023-02-23	Aesculap Implant Systems LLC	Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
2022-12-15	Stradis Healthcare	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2022-12-15	Stradis Healthcare	Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
2021-11-24	Howmedica Osteonics Corp.	Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N:
2019-06-10	Zimmer Biomet, Inc.	Lack of an adequate sterilization validation.
2019-06-10	Zimmer Biomet, Inc.	Lack of an adequate sterilization validation.

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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.