Browse Device Recalls

160 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 160 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 160 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jul 7, 2016	Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10...	Increase in the failure rate of certain low-voltage DC power supplies (DCPS)	Class II	Philips Electronics North America Corporation
Jul 7, 2016	UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD...	Increase in the failure rate of certain low-voltage DC power supplies (DCPS)	Class II	Philips Electronics North America Corporation
Apr 14, 2016	HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the t...	MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may hav...	Class II	Philips Electronics North America Corporation
Mar 15, 2016	Philips Healthcare System X-ray Tomography Computed :	It was discovered the patient support tabletop may fail to move in the horizontal direction when...	Class II	Philips Electronics North America Corporation
Mar 15, 2016	Philips Healthcare System X-ray Tomography Computed :	It was discovered the patient support tabletop may fail to move in the horizontal direction when...	Class II	Philips Electronics North America Corporation
Feb 10, 2016	eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A dis...	eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, ...	Class II	Philips Electronics North America Corporation
Feb 10, 2016	evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable ...	eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, ...	Class II	Philips Electronics North America Corporation
Jan 4, 2016	Philips IntelliVue Module Measurement X2 Model: M3002A	The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ...	Class II	Philips Electronics North America Corporation
Jan 4, 2016	Philips IntelliVue Measurement Module X1 Model: M3001A	The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ...	Class II	Philips Electronics North America Corporation
Nov 25, 2015	Philips Healthcare IntelliVue Info Center iX, A.0 866023	Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w...	Class II	Philips Electronics North America Corporation
Nov 25, 2015	Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, P...	Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w...	Class II	Philips Electronics North America Corporation
Nov 25, 2015	Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Moni...	Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG w...	Class II	Philips Electronics North America Corporation
Nov 20, 2015	Cardinal Health Tiny Toes; 11470-010T Infant heel warmer	Heel warmers may cause first and second degree burns.	Class II	Philips Electronics North America Corporation
Nov 3, 2015	UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovas...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovas...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.	Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the el...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 syste...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular a...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is in...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated ...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 300...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on hum...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.	Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the el...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 s...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 syste...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 30...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicia...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 syst...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated va...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 syste...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardi...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular an...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovas...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system ...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Card...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 300...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Nov 3, 2015	Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 72...	The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live...	Class II	Philips Electronics North America Corporation
Oct 14, 2015	Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,...	The following MRx software issue has been identified: MRx model M3535A with software version F.03...	Class II	Philips Electronics North America Corporation
Oct 1, 2015	Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura...	Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.	Class II	Philips Electronics North America Corporation
Sep 17, 2015	Philips DuraDiagnost stationary X-ray system	Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which ca...	Class II	Philips Electronics North America Corporation
Jul 22, 2015	Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A ra...	If arm is not fastened securely it could fall down.	Class II	Philips Electronics North America Corporation
Jul 6, 2015	Actuator for angiographic x-ray monitor ceiling suspension system. Actuator ...	The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped ...	Class II	Philips Electronics North America Corporation
Jul 6, 2015	SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T an...	Wrong positioning of the coil cables can create unintended resonances via the patient or elevated...	Class II	Philips Electronics North America Corporation

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.