Class IIOngoingZ-2531-2026
Zimmer, Inc. recalls Off-Axis Alliance Glenoid
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer, Inc.INJul 1, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 1,121 recalls
Class IIOngoingZ-2530-2026
Zimmer, Inc. recalls Off-Axis Alliance Glenoid
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer, Inc.INJul 1, 2026
Class IIOngoingZ-2529-2026
Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer, Inc.INJul 1, 2026
Class IIOngoingZ-2528-2026
Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer, Inc.INJul 1, 2026
Class IIOngoingZ-2527-2026
Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System Small
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Zimmer, Inc.INJul 1, 2026
Class IIOngoingZ-2526-2026
PFM MEDICAL INC. recalls Multi-Snare Set: 5 mm x 125 cm
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a…
PFM MEDICAL INC.CAJul 1, 2026
Class IIOngoingZ-2520-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2519-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Numb…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2518-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits M…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2478-2026
MITO RED LIGHT INC recalls Mito Red Light
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
MITO RED LIGHT INCAZJun 24, 2026
Class IIOngoingZ-2462-2026
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB)…
- Polymer/Metal/Polymer Coated Porous Uncemented Semi-Constrained Patello/Femorotibial Knee Prosthesis
- Under Investigation by firm
Howmedica Osteonics Co…NJJun 24, 2026
Class IIOngoingZ-2461-2026
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB)…
- Polymer/Metal/Polymer Coated Porous Uncemented Semi-Constrained Patello/Femorotibial Knee Prosthesis
- Under Investigation by firm
Howmedica Osteonics Co…NJJun 24, 2026