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 14561–14580 of 38,428 recalls
Recalled Item: CADD Administration Sets
The Issue: Product may have been manufactured with an air
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wuxi Nest
The Issue: The firm is replacing all tubes that were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N
The Issue: When a Clot Detection Error is generated during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212)
The Issue: When a Clot Detection Error is generated during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N
The Issue: When a Clot Detection Error is generated during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) -
The Issue: Hardware error- Hot Plugging feature could cause an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor
The Issue: The oxygen sensor for certain CARESCAPE R860 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed
The Issue: The previous software application version (1.1.300) is missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENNOVATE MIS REMOVALKEY SHORT
The Issue: Fracture or breakage of the spinal fixation arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected)
The Issue: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2...
The Issue: Incorrect lot number for Standard Oral Fluid Negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro
The Issue: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products BuBc Slides - in vitro diagnostic use
The Issue: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate...
The Issue: Incorrect lot number for Standard Oral Fluid Negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
The Issue: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene...
The Issue: Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mako Hip End Effector
The Issue: Characterization issue associated with the product. This issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are
The Issue: risk of brush detachment during cleaning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.