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.
Showing 14181–14200 of 38,428 recalls
Recalled Item: EMPOWR Acetabular System *** EMPOWR Acetabular Cup
The Issue: Due to incomplete machining a small peg remnant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX ULTRA HA 6.5 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.
Recalled Item: BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX ULTRA PLLA HA 6.5MM 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.
Recalled Item: HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEORAPTOR 2.9 W/ 1 UB COBRAID 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.
Recalled Item: OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--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.
Recalled Item: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK-
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- 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.
Recalled Item: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor
The Issue: Product packaging improper or incomplete seal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULTRA FAST-FIX AB ASSEMBLY - CURVED-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.
Recalled Item: TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-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.
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.
Recalled Item: HEALICOIL RSB SA 5.5MM 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.
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.
Recalled Item: TWINFIX ULTRA HA 4.5 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.