Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 2,801–2,850 of 7,959

Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
S8-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X7-2t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C5-2 Lumify Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L15-7io Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
XL14-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
S3-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
S9-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C10-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L12-5 50 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X6-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L15-7IO TRANSDUCER Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L12-5 38mm Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
OMNI II TEE Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
7.5MHZ Endo Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L9-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X7-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C8-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L12-4 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
SCNHD LA L7-4 HDI Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C9-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X5-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C8-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
3D9-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L18-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
VL13-5 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
S4-1 Lumify Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Orascoptic Surgical Acuity
Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Class II
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
D2cwc Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
mL26-8 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
eL18-4 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
mC12-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L12-4 Lumify Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
C9-4v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
3D6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
S8-3t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
D5cwc Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
Transducer C10-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
X11-4t Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
L12-3 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 3, 2025
Philips Ultrasound, Inc
c5-1 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Class III
Medical Device Recall · July 2, 2025
GE Medical Systems, LLC
GE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Class II
Medical Device Recall · July 2, 2025
GE Medical Systems, LLC
GE HealthCare OEC 9800.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Class II
Medical Device Recall · July 2, 2025
Stryker Corporation
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Class II