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 14161–14180 of 38,428 recalls

September 9, 2020· Smith & Nephew, Inc.

Recalled Item: OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number:

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number:

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product...

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number:

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product...

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL--

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number:

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number:

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing
September 9, 2020· Smith & Nephew, Inc.

Recalled Item: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK--

The Issue: Product packaging improper or incomplete seal of the

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

Class II — Potential Health HazardOngoing