Browse Device Recalls

34,057 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,057 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 34,057 FDA device recalls — Class II.

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Date	Product	Reason	Class	Firm
Dec 19, 2025	Alphenix INFX-8000F, interventional fluoroscopic x-ray system	It has been discovered that there is a possibility that the fixing screws of the ceiling movement...	Class II	Canon Medical System, USA, INC.
Dec 19, 2025	Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ...	The supplier manufactured anatomical left plates with an incorrect thread orientation.	Class II	Tyber Medical
Dec 19, 2025	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R...	Needle free access device intended as accessory to vascular access used in hemodialysis or access...	Class II	ICU Medical, Inc.
Dec 19, 2025	VANTAGE GALAN 3T Model MRT-3020/MEXL-3020	There is a potential for formation of ice occurring in the venting system of the superconducting ...	Class II	Canon Medical System, USA, INC.
Dec 18, 2025	Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a...	Potential for fraying on the body support strap.	Class II	Community Products, LLC
Dec 18, 2025	Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE...	Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly...	Class II	Vascutek, Ltd.
Dec 18, 2025	Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a g...	Potential for fraying on the body support strap.	Class II	Community Products, LLC
Dec 18, 2025	Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered ...	Potential for fraying on the body support strap.	Class II	Community Products, LLC
Dec 18, 2025	Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784...	Due to product that may contain a void in the material that separates the wire guide and cutting ...	Class II	Wilson-Cook Medical Inc.
Dec 17, 2025	Genesis Screw-In Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	Genesis Dual Thread Screw-In Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	AlternatiV+ Max Knotless Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	Genesis Knotless Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	Fixone Hybrid Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	Fixone Biocomposite Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	Genesis Push-In Suture Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 17, 2025	AlternatiV+ Screw-In Anchor	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre...	Class II	Aju Pharm Co., Ltd.
Dec 16, 2025	Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Rumex Disposable Diamond Dusted ILM Elevator, 12-7523	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2....	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07...	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	25GA Subretinal Injection Cannula VS0220.25	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Tecfen Retractable Membrane Polisher, QTPR1267-23	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I...	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02...	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Vortex Surgical I2 Injection Kit, VS0500	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Vortex Surgical TID Pharos Illuminated Depressor, VS0801B	XXX	Class II	Vortex Surgical Inc.
Dec 16, 2025	Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L...	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 16, 2025	Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ...	Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20...	Class II	Medline Industries, LP
Dec 16, 2025	Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C...	There may be voids located in the seal of Tyvek pouches associated with identified catalog number...	Class II	Vortex Surgical Inc.
Dec 15, 2025	Allura Xper FD20; Model Number: 722006;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD10; Model Number: 722026;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10	Nasal feeding tube packaged without the nasal transfer tube component.	Class II	Wilson-Cook Medical Inc.
Dec 15, 2025	Allura Xper FD20 Biplane; Model Number: 722013;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD20 OR Table; Model Number: 722023;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.	Presence of particulates in affected devices that can be deposited into breast tissue during use.	Class II	Hologic, Inc
Dec 15, 2025	Plum Duo Infusion System, List Number 40002-04-01	ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro...	Class II	ICU Medical, Inc.
Dec 15, 2025	Allura Xper FD20 Biplane; Model Number: 722008;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl...	Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a...	Class II	Sysmex America, Inc.
Dec 15, 2025	Allura Xper FD10; Model Number: 722010;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021...	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the...	Class II	ICU Medical, Inc.
Dec 15, 2025	Allura Xper FD20/10; Model Number: 722029;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ...	Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted...	Class II	Diagnostica Stago, Inc.
Dec 15, 2025	Allura Xper FD20; Model Number: 722012;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.