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 13461–13480 of 38,428 recalls
Recalled Item: Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN
The Issue: There is the potential of a bent or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Hypodermic Syringe 10 ml
The Issue: The product packaging for the 10 ml eccentric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Acute Care System (IACS) Monitoring Solution: The IACS is
The Issue: The Infinity M540 patient monitor may randomly reboot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. Clavicle Plating System
The Issue: The instruments may become cold welded together when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EOSedge system may acquire two simultaneous orthogonal planar images
The Issue: Inadequate images resizing and 2D measurement errors may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquarius LPH 511-A CRLF2 Distal Probe Green
The Issue: Users may observe very faint additional locus specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used
The Issue: FUJIFILM has become aware that incorrect concentration values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement
The Issue: Ionized calcium test on some i-STAT CG8+ and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of
The Issue: Ionized calcium test on some i-STAT CG8+ and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge CM320 Series Washer Disinfector - Product Usage: A multi
The Issue: The potential that the plastic inlet hose connections
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set
The Issue: There were customer reports of separation between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no:
The Issue: Complaints were received reporting of Staphylococcus aureus (ATCC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended
The Issue: Acetabular Liners have a higher than acceptable oxidation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner.
The Issue: Acetabular Liners have a higher than acceptable oxidation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.
The Issue: Medical device non-conformance to electrical safety standard (IEC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner.
The Issue: Acetabular Liners have a higher than acceptable oxidation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Acapella DH Vibratory PEP Device - Product Usage: a
The Issue: Shipping box may contain wrong model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700
The Issue: Misleading error messages and a gap in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Multirall 200 overhead lift- overhead lift is a general-purpose
The Issue: Multirall Q-link strap lock has not been fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSABOND AB 40 GRAMS FORMULATION 2
The Issue: heat and humidity exposure. The affected lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.