Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

Date	Product	Reason	Class	Firm
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 6, 2026	Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR	Software anomaly in the patient positioning system may result in positional discrepancy.	Class II	Hitachi, Ltd. Radiation Oncology Systems, Kashi...
Feb 3, 2026	IBA Proton Therapy System - PROTEUS 235	It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy S...	Class II	Ion Beam Applications S.A.
Jan 30, 2026	DxC 700 AU, REF: B86444, B86446	A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal...	Class II	Beckman Coulter Mishima K.K.
Jan 30, 2026	CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281	A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal...	Class II	Beckman Coulter Mishima K.K.
Jan 27, 2026	CLARITY II Laser System; Model No. 1110200210.	Reports of devices sparking/popping and potentially burning patients.	Class II	Lutronic Corporation
Jan 26, 2026	Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 26, 2026	Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa...	Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 21, 2026	EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5	Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism wer...	Class II	Staar Surgical AG
Jan 15, 2026	MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010	Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or ca...	Class II	KOB GmbH
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/16;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/09;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-2836/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-2835/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/15;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8521/15;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-8030/12;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 12, 2026	Endo-Model Replacement Plateau; Item Number: 15-0027/11;	The potential for an implant with a plateau screw where the bushing could detach from the screw s...	Class II	Waldemar Link GmbH & Co. KG (Mfg Site)
Jan 9, 2026	Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;	Internal investigations have identified an issue with the durability of the connecting cable near...	Class II	Maquet Cardiopulmonary Gmbh
Jan 9, 2026	Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca...	Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	Class II	Medartis AG
Jan 9, 2026	Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Ca...	Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	Class II	Medartis AG
Jan 5, 2026	Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI...	Due to a modification by a vendor and may be reinstalled without properly engaging the outside re...	Class II	Raz Design Inc
Dec 19, 2025	Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemol...	Product not cleared by the FDA.	Class II	Altruan GmbH
Dec 19, 2025	Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococ...	Product not cleared by the FDA.	Class II	Altruan GmbH
Dec 19, 2025	Clearest Strep-A Cassette Test. Test to determine the presence of group A str...	Product not cleared by the FDA.	Class II	Altruan GmbH
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 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.
Nov 22, 2025	Vivoo Vaginal pH Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Menopause Test Cassette (Urine)	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	LH One Step Ovulation Test Device (Urine)	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025	Vivoo pH Test	Test strips and other tests including for near-patient testing, that require a 510(k) were distri...	Class II	Changchun Wancheng Bio-Electron Co., Ltd.

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.