Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear

Date	Product	Reason	Class	Firm
Nov 19, 2019	Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ...	Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019	Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calib...	Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-D...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019	OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Numbe...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 19, 2019	Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ...	Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ...	Class I	Philips Respironics, Inc.
Nov 18, 2019	Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. T...	The devices were mislabeled with the incorrect product size resulting in 16Fr devices being label...	Class II	W. L. Gore & Associates Inc.
Nov 18, 2019	Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020	Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platf...	Class II	Paltop Advanced Dental Solutions Ltd
Nov 18, 2019	There is a complaint regarding internal check cable guide mechanism failure f...	A component failure may lead to treatment interruption or incorrect source positioning.	Class II	Nucletron BV
Nov 18, 2019	Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Ster...	Elasto-Gel Wound Dressing may be contaminated with mold.	Class II	Southwest Technologies Inc
Nov 18, 2019	STA UNICALIBRATOR (ref. 00675)	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX...	Class II	Diagnostica Stago, Inc.
Nov 18, 2019	STA SYSTEM CONROL N + P (ref. 00678)	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX...	Class II	Diagnostica Stago, Inc.
Nov 18, 2019	Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product...	During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the...	Class II	Boston Scientific Corporation
Nov 18, 2019	Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product...	During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the...	Class II	Boston Scientific Corporation
Nov 18, 2019	LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case	Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specif...	Class III	LivaNova USA Inc.
Nov 18, 2019	RayStation stand-alone software treatment planning system, Model Numbers 4.0,...	Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of...	Class II	RAYSEARCH LABORATORIES AB
Nov 18, 2019	BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system...	BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than spe...	Class II	Leica Microsystems, Inc.
Nov 18, 2019	ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 ...	Registering dose and structures in the treatment delivery workflow could result in an alignment d...	Class II	Viewray, Inc.
Nov 15, 2019	O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000	Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ...	Class II	Medtronic Navigation, Inc.-Littleton
Nov 15, 2019	AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of ca...	The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack o...	Class III	Tosoh Smd Inc
Nov 15, 2019	Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L	There is the potential presence of particular matter in the header caps of ten lots the Revaclear...	Class II	Baxter Healthcare Corporation
Nov 15, 2019	Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130	Potential leak in the balloon extension line. If a leak was present and went undetected during pr...	Class II	Arrow International Inc
Nov 15, 2019	Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J	Potential leak in the balloon extension line. If a leak was present and went undetected during pr...	Class II	Arrow International Inc
Nov 15, 2019	PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende...	A defect involving an occluded needle was discovered during a training exercise.	Class I	Tytek Medical Inc
Nov 14, 2019	HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromoge...	False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (AT...	Class II	Hardy Diagnostics
Nov 14, 2019	FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938...	Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke...	Class II	Abbott Diabetes Care, Inc.
Nov 14, 2019	Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351	Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in t...	Class II	Medtronic Perfusion Systems
Nov 14, 2019	Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R....	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI...	Class II	Cardinal Health Inc.
Nov 14, 2019	S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst...	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI...	Class II	Cardinal Health Inc.
Nov 14, 2019	Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653	Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke...	Class II	Abbott Diabetes Care, Inc.
Nov 14, 2019	Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 1009...	In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collis...	Class II	Siemens Medical Solutions USA, Inc
Nov 14, 2019	Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys...	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI...	Class II	Cardinal Health Inc.
Nov 14, 2019	Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,...	Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke...	Class II	Abbott Diabetes Care, Inc.
Nov 13, 2019	Lamicel 20PK 3MM INTL Cervical dilator	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Nov 13, 2019	Lamicel 20PK 5MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Nov 13, 2019	Lamicel 10PK 10MM INTL	Routine sterilization dose does not meet the required Sterility Assurance Level.	Class II	Medtronic Xomed, Inc.
Nov 13, 2019	Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1G...	A component used within the side rail mechanism may malfunction, resulting in the side rail eithe...	Class II	Linet Spol. S.r.o.
Nov 13, 2019	Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane...	Sterile barrier system may be compromised	Class II	GETINGE US SALES LLC
Nov 12, 2019	CARESCAPE Central Station - Product Usage: The intended use is to provide cli...	When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v...	Class II	GE Healthcare, LLC

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.