Class IIOngoingZ-1510-2026
Exactech, Inc. recalls Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number…
Impactor handle may be missing cross-pin
Exactech, Inc.FLMar 18, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 973–984 of 3,866 recalls
Class IIOngoingZ-1509-2026
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Nu…
Impactor handle may be missing cross-pin
Exactech, Inc.FLMar 18, 2026
Class IIOngoingZ-1498-2026
Raz Design Inc recalls Raz-AT (Attendant Tilt) Mobile Shower Commode Chair
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Raz Design IncMar 18, 2026
Class IIOngoingZ-1497-2026
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration.…
Ion Beam Applications…Mar 18, 2026
Class IIOngoingZ-1496-2026
Becton Dickinson & Company recalls 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-ste…
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Becton Dickinson & Com…NJMar 18, 2026
Class IIOngoingZ-1495-2026
KOB GmbH recalls MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
KOB GmbHMar 18, 2026
Class IIOngoingZ-1494-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: Shoc…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1493-2026
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor M…
Behind-the-ear sound processer packaging label is different then included product.
Advanced Bionics, LLCCAMar 11, 2026
Class IIOngoingZ-1492-2026
Vascutek, Ltd. recalls Gelsoft Plus
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.…
Vascutek, Ltd.Mar 11, 2026
Class IIOngoingZ-1491-2026
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model…
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Diagnostica Stago, Inc…NJMar 11, 2026
Class IICompletedZ-1490-2026
ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
ESAOTE S.P.A.Mar 11, 2026
Class IIOngoingZ-1489-2026
Olympus Corporation Of The Americas recalls Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. T…
Potential for rubber fragment detachment during use.
Olympus Corporation of…PAMar 11, 2026