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 37441–37460 of 38,428 recalls
Recalled Item: Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage:
The Issue: Digital Skin Mammography Marker separating from the backing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Finapres Medical Systems Portapres with NiMh battery pack Product Usage:
The Issue: Battery may become hot and leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok...
The Issue: ConMed Linvatec recalled one lot of their PopLok
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic
The Issue: Baxter discovered that a Baxter technical service representative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroCool Breathable Gown with Towels
The Issue: Package seam of some units may not remain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is
The Issue: Package seam of some units may not remain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aviator Drill Bit (10 mm
The Issue: Aviator drill bits are 10 mm longer than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes(R) Hemostatic Bone Putty
The Issue: There is the potential for Hemostatic Bone Putty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer
The Issue: A customer has reported an error on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ABL software version 6.12 for the ABL800 and ABL700
The Issue: A customer has reported an error on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ABL software version 6.12 for the ABL800 analyzer. The
The Issue: A customer has reported an error on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is
The Issue: The IntraOs 70 system was found to have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545
The Issue: Three complaints have been filed where the Hoffman
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are
The Issue: The values reported for PCO2 by BP7561 B-Lac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verify¿ Bowie-Dick Test Card
The Issue: STERIS has learned that the Verify Bowie Dick
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white
The Issue: Distal part of the anchor may break on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white
The Issue: Distal part of the anchor may break on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue
The Issue: Distal part of the anchor may break on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor
The Issue: Distal part of the anchor may break on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.