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 2981–3000 of 38,428 recalls
Recalled Item: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn
The Issue: that the induction seal is not completely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Large Volume Pump Software, version 5.9.2 and earlier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel
The Issue: Due to manufacturing issue (unintended by-product of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and
The Issue: Product complaints were received describing the A820 myPTM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number:...
The Issue: The machine side connector of the filter HME
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger
The Issue: The machine side connector of the filter HME
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY
The Issue: Kits contain recalled components due to reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2
The Issue: Kits contain recalled components due to reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK
The Issue: Labeling update to include a contraindication statement against
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS
The Issue: Labeling update to include a contraindication statement against
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK
The Issue: Labeling update to include a contraindication statement against
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK
The Issue: Labeling update to include a contraindication statement against
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Precision Thin
The Issue: Precision Thin blade attachments have a potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Pyxis MedStation ES
The Issue: Software issues could potentially result in: 1) delays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MSOT Acuity Echo is a Class 4 medical laser
The Issue: The MSOT Acuity Echo does not include an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) BD Pyxis MedStation ES
The Issue: Labeling is insufficient regarding delays in access to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Precision Thin
The Issue: Precision Thin blade attachments have a potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a
The Issue: Three lots of Rapid fFN Specimen Collection kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6.
The Issue: Sysmex was made aware of a report of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E
The Issue: It was identified internally that two commingle events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.