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 28121–28140 of 38,428 recalls
Recalled Item: Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463
The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem VELOCITY Automated Urine Chemistry
The Issue: Iris International noted loose or missing analyte pads
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF
The Issue: The Firm has discovered a Software bug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Astral 100
The Issue: Resmed Corporation is recalling Astral 100, 150 External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Super Arrow-Flex Percutaneous Sheath Introducer Sets or CL-07635
The Issue: Arrow has issued a recall for these products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation
The Issue: for a component contained in the Implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Microsystems (Schweiz) Ag. The common name of the device
The Issue: An electronic component of the Leica M525 OH4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 25 consists of all product under product code: LPH
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 48 consists of all product under product code: JWH
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 12 consists of all product under product code JDI
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 31 consists of all product under product code: KTT
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 29 consists of all product under product code: LPHand
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 52 consists of product code: HWC and same usage:
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 18 consists of all product under product code: HWC
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 5 consists of all products under product code HWC
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 28 consists of all product under product code: JDI
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 51 consists of all product under product code: JWH
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 36 consists of all product under product code: HSB
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 17 consists of all product under product code: LPH
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product 45 consists of all product under product code: JWH
The Issue: As a result of the insufficient sealer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.