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 3861–3880 of 38,428 recalls
Recalled Item: a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed
The Issue: The beds have a potential for an interface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable...
The Issue: The reason for this recall is PTS Diagnostics,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MST Duet Reusable Handle for Single Use Heads
The Issue: Due to pin coming off of handles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The IMAGEnet 6 Ophthalmic Data System is a software program
The Issue: The overlay of visual field test locations on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use
The Issue: A Gen 5 tail piece was assembled to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories
The Issue: There is discrepant labeling on the inner and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cartesion Prime
The Issue: When PET-CT system is executing reconstruction, if PET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing...
The Issue: The Quantimetrix Dipper Urinalysis Dipstick control was shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Graft Tube is an optional instrument which
The Issue: detachment of the Graft Tube shaft from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phasitron5 Breathing Circuit (P5-10
The Issue: As a result of product complaints, breathing circuits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu¿ VivaSight 2 DLT Endobronchial tube
The Issue: Ambu has received complaints on Ambu¿ VivaSight 2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with
The Issue: Epoxy used to seal the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Check-Flo Performer Introducer Set
The Issue: Cook Medical is conducting removal of a lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Cystoscope Outer Sheath
The Issue: Product being removed due to incompatibility when used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number:
The Issue: Olympus is removing the statement of compatibility with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for
The Issue: The High and Low Control acceptance ranges in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon- Indicated for use in adult and
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing
The Issue: There is a potential for pinholes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800 Infusion System
The Issue: There is a defect in the air-in-line software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iotaSOFT Plus Drive Unit
The Issue: Incorrect GTIN number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.