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 24401–24420 of 38,428 recalls
Recalled Item: VITEK¿ 2 Gram Negative Susceptibility card (AST-N293)
The Issue: The integrity of the product container may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Acumed Slide-Loc Anatomic Radial Head System is intended for
The Issue: The firm initiates a voluntary removal and discontinue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VORTRAN Automatic Resuscitator
The Issue: Vortran received a customer complaint that the spin-nut-DSS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VORTRAN Automatic Resuscitator
The Issue: Vortran received a customer complaint that the spin-nut-DSS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microfil Composite Instruments are packaged in an unsealed plastic sleeve
The Issue: Microfil Composite Instruments were distributed with a sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: High Frequency Resection Electrodes
The Issue: Loop wires breaking at the distal end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES System and ARIES M1 System
The Issue: The hand-held barcode scanner that is used as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: White OR Towels
The Issue: Lint present on sterile Operating Room Towels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blue OR Towels
The Issue: Lint present on sterile Operating Room Towels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENVOY 500 ISE CALIBRATOR KIT
The Issue: ELITech Clinical Systems SAS initiated this recall because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent
The Issue: Firm has identified that ARCHITECT SHBG results generated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SonarMed AirWave Monitor
The Issue: for the presence of two error codes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonabsorbable suture anchor system intended to reattach soft tissue to
The Issue: Manufactured with the incorrect anchor outer body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail
The Issue: nail not properly engaging with the targeting jig
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number:...
The Issue: Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSI
The Issue: Cardiovascular Systems, Inc. (CSI). has initiated a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use
The Issue: Reports of the Canister Carrier breaking during absorbent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.