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 6341–6360 of 38,428 recalls

December 21, 2023· Paragon 28, Inc.

Recalled Item: Phantom TTC Nail

The Issue: Medical devices distributed, prior to sterilization

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

Class II — Potential Health HazardOngoing
December 21, 2023· Paragon 28, Inc.

Recalled Item: Phantom TTC Nail

The Issue: Medical devices distributed, prior to sterilization

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

Class II — Potential Health HazardOngoing
December 21, 2023· AMD Medicom Inc.

Recalled Item: PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG

The Issue: Level 3 masks were produced on alternate non-validated

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

Class II — Potential Health HazardOngoing
December 21, 2023· AMD Medicom Inc.

Recalled Item: HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)

The Issue: Level 3 masks were produced on alternate non-validated

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

Class II — Potential Health HazardOngoing
December 21, 2023· AMD Medicom Inc.

Recalled Item: HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item

The Issue: Level 3 masks were produced on alternate non-validated

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

Class II — Potential Health HazardOngoing
December 21, 2023· G & H Wire Company

Recalled Item: FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics

The Issue: Latex elastic bands were labeled as non-latex elastic

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

Class II — Potential Health HazardOngoing
December 21, 2023· Cardinal Health 200, LLC

Recalled Item: CardinalHealth Suction Canister Liner

The Issue: The above-listed lots of Cardinal Health Medi-Vac CRD"

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

Class II — Potential Health HazardOngoing
December 21, 2023· Ivoclar Vivadent, Inc.

Recalled Item: Article No. NA6050411

The Issue: Affected product may not perform as expected; the

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

Class II — Potential Health HazardOngoing
December 21, 2023· Covidien LP

Recalled Item: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT...

The Issue: Specific lots of sutures were sterilized with gamma

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE COLLECTION KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE BOTTLE KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE ADULT BLOOD CULTURE KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE TRAY ADULT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· Covidien LP

Recalled Item: Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21

The Issue: Specific lots of sutures were sterilized with gamma

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

Class II — Potential Health HazardOngoing
December 21, 2023· MICROVENTION INC.

Recalled Item: TERUMO HydroPearl Compressible Microspheres for Embolisation

The Issue: Due to, during the manufacturing process, the prescribed

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

Class II — Potential Health HazardOngoing
December 21, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE BLOOD CULTURE COLLECTION KIT

The Issue: Medline Industries, LP is issuing a recall for

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

Class II — Potential Health HazardOngoing
December 21, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health Suction Canister Liner

The Issue: The above-listed lots of Cardinal Health Medi-Vac CRD"

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

Class II — Potential Health HazardOngoing
December 21, 2023· Cardinal Health 200, LLC

Recalled Item: Cardinal Health MEDI-VAC CRD Suction Canister Liner

The Issue: The above-listed lots of Cardinal Health Medi-Vac CRD"

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

Class II — Potential Health HazardOngoing