Class IIOngoingZ-1061-2026
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. recalls BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip
Labeling error, Incorrect expiration date
HANGZHOU BEVER MEDICAL…Jan 21, 2026
Recalls: Labeling Change Control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 69 recalls
Class IIOngoingZ-1041-2026
Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray S…
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Mobius Imaging, LLCMAJan 21, 2026
Class IIOngoingZ-1040-2026
Mobius Imaging, LLC recalls Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray S…
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Mobius Imaging, LLCMAJan 21, 2026
Class IIOngoingZ-0722-2026
DJO, LLC recalls Cold Form Wrap: Back
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capa…
DJO, LLCCADec 3, 2025
Class IIOngoingZ-0571-2026
Greiner Bio-One North America, Inc. recalls Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Cata…
Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat te…
Greiner Bio-One North…NCNov 26, 2025
Class IIIOngoingZ-2517-2025
Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalls FloPatch FP120
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Flosonics Medical (R/A…Sep 10, 2025
Class IIOngoingZ-2345-2025
Dynex Technologies, Inc. recalls Dynex Agility Sample Tips
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with…
- Labeled Or Promoted For A Specific Medical Use General Purpose Laboratory Equipment
- Labeling Change Control
Dynex Technologies, In…VAAug 27, 2025
Class IIOngoingZ-2286-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS
Knee implants contain incorrect labeling (size and/or side incorrect)
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXAug 20, 2025
Class IIOngoingZ-2285-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS
Knee implants contain incorrect labeling (size and/or side incorrect)
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXAug 20, 2025
Class IIOngoingZ-2280-2025
SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model…
Cannulated fenestrated polyaxial screws may be incorrectly labeled
SPINEART SAAug 20, 2025
Class IIOngoingZ-2279-2025
SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model…
Cannulated fenestrated polyaxial screws may be incorrectly labeled
SPINEART SAAug 20, 2025
Class IIOngoingZ-1963-2025
Microtek Medical, Inc. recalls Microtek Patient Drape ECOLAB AP6MMN Patient Drape
Due to non-sterile products being labeled as sterile
Microtek Medical, Inc.GAJun 18, 2025