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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2901–2920 of 39,430 recalls

Class IIOngoing

Orascoptic Superior Visualization Custom loupes with Dragonfly frames

Orascoptic Surgical Acuity

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

July 3, 2025 · DeviceView details →
Class IIIOngoing

D2TCD Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class III
Ongoing

C5-2 Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

L15-7IO TRANSDUCER Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

X7-2t Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIOngoing

Orascoptic Superior Visualization Custom loupes configured with Phantom Frames

Orascoptic Surgical Acuity

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

July 3, 2025 · DeviceView details →
Class IIIOngoing

L17-5 Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

C10-3v Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIOngoing

Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

Orascoptic Surgical Acuity

Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.

July 3, 2025 · DeviceView details →
Class IIIOngoing

C9-5ec Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

S8-3 Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

S12-4 Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

S7-2t Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIIOngoing

X3-1 Transducer Probe

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

July 3, 2025 · DeviceView details →
Class IIOngoing

GE HealthCare OEC 9900 Elite C-arm Systems.

GE Medical Systems, LLC

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.

July 2, 2025 · DeviceView details →
Class IIOngoing

GE HealthCare OEC 9800.

GE Medical Systems, LLC

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.

July 2, 2025 · DeviceView details →
Class IIOngoing

Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

Spark Biomedical Inc

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

July 2, 2025 · DeviceView details →
Class IIOngoing

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

Stryker Corporation

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.

July 2, 2025 · DeviceView details →
Class IIOngoing

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

North American Rescue LLC.

Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

July 1, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

Carefree Surgical Specialties

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

July 1, 2025 · DeviceView details →
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