FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 241–260 of 1,000 recalls

Class IIOngoing

Halyard, Pain Pack. Kit Code: AMPK48-01.

AVID Medical, Inc.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

April 30, 2026 · DeviceView details →

Class IIOngoing

BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →

Ongoing

Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A

Advanced Bionics, LLC

Due to incorrect shelf-life expiration date.

April 30, 2026 · DeviceView details →

Class IIOngoing

Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

BD Pyxis MedStation ES REF: 323 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →

Class IIOngoing

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20

Avanos Medical, Inc.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

April 30, 2026 · DeviceView details →

Class IIOngoing

Halyard, Drape Pack. Kit Code: LMDP36-01.

AVID Medical, Inc.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

April 30, 2026 · DeviceView details →

Class IIOngoing

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

April 30, 2026 · DeviceView details →

Class IIOngoing

BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →

Class IIOngoing

Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)

SURGIFY MEDICAL OY

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

April 30, 2026 · DeviceView details →

Class IIOngoing

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

CareFusion 303, Inc.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

April 30, 2026 · DeviceView details →

← PreviousPage 13 of 50Next →