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 35961–35980 of 38,428 recalls
Recalled Item: A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set
The Issue: Customers have reported that when separating an individual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set
The Issue: Customers have reported that when separating an individual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code:
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit
The Issue: Customers have reported that when separating an individual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with...
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOTECH Endoscope Cleaner and Reprocessor System
The Issue: Advanced Sterilization Products (ASP) is recalling the EVOTECH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit
The Issue: Customers have reported that when separating an individual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Product...
The Issue: Unable to pass catheter through outer sheath during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking
The Issue: Stryker Orthopaedics has received a report indicating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MSK EXTREME MR SCANNER
The Issue: Coolant supply lines may leak liquid onto the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR430s MRI Scanner
The Issue: Coolant supply lines may leak liquid onto the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Belly Bag Urine Collection Bag with Hip Belt. The product
The Issue: Sterile packaging may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCS3011 AV Loop Kit For use with Transonic CO status System Only
The Issue: Transonic Systems Inc. have received complaints of blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens brand ACUSON SC2000 Ultrasound System
The Issue: When using the V5M transducer, the display of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7
The Issue: Zimmer is initiating a lot specific recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Summit Medical
The Issue: Summit Medical has initiated a recall of Myringotomy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip
The Issue: The pre-vacuum steam sterilization (wrapped method) temperature in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.