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 16901–16920 of 38,428 recalls
Recalled Item: Canister HFC-134a /1000g
The Issue: The canister neck bushing may become loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canister HFC-134a / 980g
The Issue: The canister neck bushing may become loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ergo 3.2mm K-wire - Product Usage: The devices is used
The Issue: for the wire to fracture at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canister HFC-134a /980g
The Issue: The canister neck bushing may become loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following
The Issue: ConvaTec has received complaints associated with use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE
The Issue: The recall is being conducted due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single
The Issue: Product has the potential to be contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm
The Issue: Modified outside of approved manufacturing process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single
The Issue: Product has the potential to be contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Embryology Heated Plate within the RI Witness
The Issue: The touchpad may not work properly after cleaning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan WalkAway-40 plus Instrument
The Issue: Instruments were manufactured with a shortened 30mL reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan WalkAway-40 plus Reconditioned Instrument
The Issue: Instruments were manufactured with a shortened 30mL reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan WalkAway-96 plus Reconditioned Instrument
The Issue: Instruments were manufactured with a shortened 30mL reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan WalkAway-96 plus Instrument
The Issue: Instruments were manufactured with a shortened 30mL reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250)
The Issue: Cross-reactivity testing may not meet the claims indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opiate 300 Ng Reagent (OP 1 X 250) for use
The Issue: Cross-reactivity testing may not meet the claims indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: lmpella CP with Smart Assist
The Issue: This one pump shipped with incorrect pump programming,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System
The Issue: It is possible that the forced electron density
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System
The Issue: It is possible that the forced electron density
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solarice Rapid Exchange Balloon Dilatation Catheter
The Issue: Medtronic has determined that some catheters have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.