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 37181–37200 of 38,428 recalls
Recalled Item: Automatic Cutting Needles
The Issue: Sterility of the product may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors...
The Issue: Inspan Compressors may break at weld causing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREVI Isola System
The Issue: The instrument may not dispense the specimen onto
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TORQ Sternal Closure Device. The common name is TWISTER
The Issue: The TORQ Sternal Closure Device, Lot 062711, is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated
The Issue: Embedded iron oxide glass defect which may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance CT 16 System Product Usage: The Brilliance 16
The Issue: Philips was notified that the system logout in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sekisui Spectrolyse PAI-1
The Issue: SPECTROLYSE PAI-1 activity assay producing lower than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves
The Issue: Trilogy Longevity Constrained Liner devices were packaged in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is
The Issue: There is a potential failure of the Integrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft
The Issue: Implants were incorrectly laser marked as 23mm instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The brand name is MRidium Series 1000 MR Infusion Sets
The Issue: Iradimed Corporation is recalling MRidium Series 1000 MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX 16-slice CT Scanner System
The Issue: On August 24, 2012 the firm recalled the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano brand Intravascular Ultrasound
The Issue: The display on the system has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia
The Issue: King Systems received a customer complaint indicating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper
The Issue: Field complaints indicate that recent shipments of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper
The Issue: Field complaints indicate that recent shipments of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Tip Marker
The Issue: Dual Tip Marker has inconsistent ink flow on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-Lift Implant Guides (also known as S-LIF) Compressor Part Number:
The Issue: When using the optional S-LIFT (also known as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-Rom¿ Total Hip System Poly Liner Packaging: The insert is
The Issue: Orthopaedics, Inc. (DePuy) is issuing a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW
The Issue: Modular necks were manufactured out of specification by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.