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 26301–26320 of 38,428 recalls
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H)
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant
The Issue: A limited number of product pouches may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released
The Issue: Roche Diabetes Care, Inc. initiated a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agee-WristJack¿ Fracture Reduction System
The Issue: A number of Agee WristJack¿ Fracture Reduction Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US
The Issue: Customers complained of low/empty reagent vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.