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 3341–3360 of 38,428 recalls
Recalled Item: Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011....
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226.
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number:
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge...
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil
The Issue: for the outer stainless-steel tube to break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis CII Safe ES
The Issue: Due to a software issue, automated dispensing cabinet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES 7 Drawer Auxiliary Tower
The Issue: Due to a software issue, automated dispensing cabinet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES
The Issue: Due to a software issue, automated dispensing cabinet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: The DxI 9000 Access Immunoassay Analyzer wash wheel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Product Name: Monarch¿ III D Delivery Cartridge
The Issue: Increase in complaints associated with a molding defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aerin Medical VivAer Stylus
The Issue: Some units in a single production lot were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST REPROCESSED BRUNS CURETTE #00 (BC00)
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magnesium Flex reagent cartridge
The Issue: Siemens Healthcare Diagnostics is recalling two lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500)
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE MAGILL FORCEP (MAGF9)
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O.R. SCISSORS
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUMMELL
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE STRT KELLY HEMOSTAT (SK8039S)
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST IUD REMOVAL HOOK 10" (504090)
The Issue: Weak seals may result in a breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.