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 61–80 of 38,428 recalls
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 5000 PAK
The Issue: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas pro integrated solutions with cobas c 503 analytical units:
The Issue: Software defect, which allows the system to accept
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
The Issue: Falsely depressed UAlb patient results may occur. Affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Universal Viewer Zero Footprint Client
The Issue: Under certain workflows, patient information shown in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805
The Issue: packaging failures, which could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Private Label CVS. Model Number: CVS405406. Helps maintain a moist
The Issue: packaging failures, which could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for
The Issue: Issue with software algorithm which may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for
The Issue: Issue with software algorithm which may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)
The Issue: packaging failures, which could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus High Flow Insufflation Unit. Model Number: UHI. Used for
The Issue: Issue with software algorithm which may lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE
The Issue: Due to labeling error. Incomplete ingredients listed. Labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING
The Issue: There is the potential for the length of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL
The Issue: Knee and Humeral socket implants contain incorrect labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD
The Issue: Knee and Humeral socket implants contain incorrect labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS
The Issue: Knee and Humeral socket implants contain incorrect labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.