Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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Date	Product	Reason	Class	Firm
Nov 4, 2021	Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980A1ENNISB	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980X1ENDIUU	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980S1ENDICU	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980X1ENDIPC	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980A3ENNISB	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980S3ENDICU	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Console"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980X1ENNISB	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector USB"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980X3ENDIUU	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Ki...	The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi...	Class II	Medtronic Neuromodulation
Nov 4, 2021	INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS	The package contents and package labeling do not match.	Class II	Wright Medical Technology Inc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980U1ENASAA	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Dual USB"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"	The firm identified that the Vscan Extend device will not power on because of depleted battery, d...	Class II	GE Healthcare, LLC
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980U1ESDIUC	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 4, 2021	Puritan Bennett 980 Series Ventilator, 980X2ESDIEC	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, w...	Class I	Covidien Llc
Nov 3, 2021	OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la...	Class II	Haag-Streit USA Inc
Nov 3, 2021	Leica Microsystems M220 F12 Microscope Systems	In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Mi...	Class II	Leica Microsystems, Inc.
Nov 3, 2021	OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4	Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la...	Class II	Haag-Streit USA Inc
Nov 2, 2021	Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be...	Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter ...	Class II	Flower Orthopedics Corporation
Nov 2, 2021	RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li...	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	The Steripath Gen2 Blood Collection System Model Number/Description 2700-...	Due to an uptick of complaints associated with premature needle retraction of blood collection sy...	Class II	Magnolia Medical Technologies, Inc.
Nov 2, 2021	SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ...	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548	Potential for open packaging seals compromising the sterility of the surgical gowns	Class II	Cardinal Health
Nov 2, 2021	EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V	Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope cont...	Class II	Olympus Corporation of the Americas
Nov 1, 2021	Hanger-Bar 2P 45cm	The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of ...	Class II	Human Care USA, Inc.
Nov 1, 2021	smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent...	Class II	Smith & Nephew, Inc.
Nov 1, 2021	smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent...	Class II	Smith & Nephew, Inc.
Nov 1, 2021	smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent...	Class II	Smith & Nephew, Inc.
Nov 1, 2021	RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol i...	When calibrating using the standard provided in the kit, the change in absorbance is lower than e...	Class II	Randox Laboratories Ltd.
Nov 1, 2021	smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent...	Class II	Smith & Nephew, Inc.
Nov 1, 2021	Hanger-Bar 2P 45cm	The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of ...	Class II	Human Care USA, Inc.
Oct 29, 2021	Wireless Footswtich used with the following Philips Allura Xper and Azurion I...	Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure	Class II	Philips North America Llc
Oct 29, 2021	NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: ...	The Instructions for Use have been updated to include: (1) Clarification that the device is int...	Class II	NuVasive Specialized Orthopedics, Inc.
Oct 29, 2021	Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity ...	M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2...	Class II	Diversatek Healthcare
Oct 28, 2021	OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE...	Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a ...	Class II	Osteomed, LLC
Oct 28, 2021	Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray...	It was noticed in production on 28.10.2021, that the final testing database gives a pass result f...	Class II	Palodex Group Oy

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.