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 16001–16020 of 38,428 recalls
Recalled Item: Atellica IM Humidity Pack (Qty 5)
The Issue: A software error is causing the analyzer to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Humidity Pack (Qty 1)
The Issue: A software error is causing the analyzer to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Brain 3.0 Application-Brain
The Issue: Some cross-sectional images from the image acquisitions of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA One 3.1 Brain Application
The Issue: Some cross-sectional images from the image acquisitions of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE¿ EXCLUDER¿ AAA Endoprosthesis
The Issue: Firm has received reports of leading end catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
The Issue: Firm has received reports of leading end catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a
The Issue: Carestream Health has discovered a potential safety problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Biopsy EnCor Probe
The Issue: Lot numbers and products inadvertently not included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Biopsy EnCor Probe
The Issue: Lot numbers and products inadvertently not included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Biopsy EnCor Probe
The Issue: Lot numbers and products inadvertently not included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Biopsy EnCor Probe
The Issue: Lot numbers and products inadvertently not included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC
The Issue: When inflating/deflating a single bladder, both bladders could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Colonoscope Model: EC38-i10L
The Issue: Distributed in the USA without an approved 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Colonoscope Model: EC34-i10L
The Issue: Distributed in the USA without an approved 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The
The Issue: The device will not connect to the Specialist
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaginal Verification Panel Lot 8208-11
The Issue: Product 8208 Vaginal Verification Panel is a 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coated VICRYL (Polyglactin 910) Suture
The Issue: Some sutures in the lot may exhibit a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure packs
The Issue: ROi CPS, LLC manufactured custom procedure packs using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.