Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 9801–9820 of 38,428 recalls

October 6, 2022· Edwards Lifesciences, LLC

Recalled Item: Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

The Issue: Due to an increase of confirmed latex deterioration

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 4, 2022· Altimate Medical, Inc.

Recalled Item: EasyStand Bantam

The Issue: Some EasyStand Bantam Small and Extra Small standers

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 4, 2022· Fresenius Medical Care Holdings, Inc.

Recalled Item: NaturaLyte Liquid Acid concentrate

The Issue: The "Nominal Chemical Composition" section of the label

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 3, 2022· Beckman Coulter, Inc.

Recalled Item: MicroScan autoSCAN-4 Instrument

The Issue: Due to MicroScan autoSCAN-4 Instruments being manufactured with

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 3, 2022· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995)

The Issue: Due to partial label detachment on tubes. This

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 3, 2022· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD Trucount Tubes (Cat. No. 663028)

The Issue: Due to partial label detachment on tubes. This

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 3, 2022· Rebiscan, Inc.

Recalled Item: Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for...

The Issue: Unable to charge the battery pack- battery packs

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
October 3, 2022· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD Trucount Tubes (Cat. No. 340334)

The Issue: Due to partial label detachment on tubes. This

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· LeMaitre Vascular, Inc.

Recalled Item: TufTex Embolectomy Catheter

The Issue: Three lots tied by two trainees were released

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· Boston Scientific Corporation

Recalled Item: EMBLEM MRI S-ICD

The Issue: There is an incorrect manufacturing date/timestamp within the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· Beaver Visitec International, Inc.

Recalled Item: Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade

The Issue: Incorrect configuration of the blades in the package

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· Baxter Healthcare Corporation

Recalled Item: Hillrom Hospital Bed Accessory

The Issue: Radio frequency emission from a functioning WatchCare device

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE DENTAL PACK

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· Boston Scientific Corporation

Recalled Item: EMBLEM S-ICD

The Issue: There is an incorrect manufacturing date/timestamp within the

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE CVC BARRIER KIT

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE RADIOLOGY PROCEDURE PACK

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: BAUSCH + LOMB BASIC OPHTHALMIC PACK

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 30, 2022· Baxter Healthcare Corporation

Recalled Item: Hillrom Hospital Bed Accessory

The Issue: Radio frequency emission from a functioning WatchCare device

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
September 30, 2022· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: BAUSCH + LOMB CATARACT TRAY

The Issue: Medline received complaints on some of the breather

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing