Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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Date	Product	Reason	Class	Firm
Sep 22, 2020	Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSI...	There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in ...	Class II	Boston Scientific Corporation
Sep 22, 2020	Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product ...	The feeding spike sets may leak at the interface of the tube and spike connector.	Class II	Cardinal Health 200, LLC
Sep 22, 2020	9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),	There is an intermittent software issue that could affect the systems, in which an exam video for...	Class II	Pentax of America Inc
Sep 22, 2020	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the qu...	Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 22, 2020	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in th...	Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 21, 2020	DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray ...	Potential malfunction in which the examination room monitor may become intermittently dysfunction...	Class II	Siemens Medical Solutions USA, Inc
Sep 21, 2020	Genesis (GII) - Product Usage: designed for use in patients in primary and re...	The anterior locking detail does not meet its design specifications.	Class II	Smith & Nephew, Inc.
Sep 21, 2020	END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	Niobe ES System, Models 001-006000-1 and 001-006100-1	There is a potential for fire in the inside computer cabinet.	Class II	Stereotaxis Inc
Sep 21, 2020	END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Confor...	Incorrect hip components were provided in kits.	Class II	Conformis, Inc.
Sep 21, 2020	END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product U...	There is a potential for a smudge artifact that could be suspect for pathology in some images due...	Class II	GE Healthcare, LLC
Sep 21, 2020	Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM...	Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever ...	Class I	Stryker Neurovascular
Sep 21, 2020	SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ...	Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG...	Class III	Synthes (USA) Products LLC
Sep 21, 2020	5.5MM Arthrogarde Hip Access Cannula	The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from ...	Class II	Smith & Nephew, Inc.
Sep 18, 2020	OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)	Product may be mislabeled.	Class II	Merete Medical GmbH
Sep 18, 2020	OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails	Product may be mislabeled.	Class II	Merete Medical GmbH
Sep 18, 2020	OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)	Product may be mislabeled.	Class II	Merete Medical GmbH
Sep 18, 2020	OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)	Product may be mislabeled.	Class II	Merete Medical GmbH
Sep 18, 2020	ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende...	There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph...	Class II	Siemens Medical Solutions USA, Inc
Sep 17, 2020	GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to p...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	LOM Disposable Surgical Gowns/Medical Gowns, Single-Use	Medical gowns distributed to customers did not include appropriate labeling, and some gowns may n...	Class II	THREAD COUNSEL INC DBA LAWS OF MOTION
Sep 17, 2020	Flow Sensor Service Part, Catalog 2087640-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Flow Sensor Service Part, Catalog 2096513-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to pro...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lat...	Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all r...	Class II	Quidel Corporation
Sep 17, 2020	9100c NXT system - Product Usage: Device is licensed and distributed outside ...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia...	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usag...	Device malfunction causing the applier to jam, and clip loading failures.	Class II	Genicon, Inc.
Sep 17, 2020	Flow Sensor Service Part, Catalog 2089610-001-S	Flow sensors could have damaged tubes in the form of small punctures or cuts.	Class II	GE Healthcare, LLC
Sep 17, 2020	Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage...	A potentially shorter than specified nebulizer connector may result in difficulty in installing t...	Class II	Getinge Group Logistics America, LLC
Sep 16, 2020	Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; ...	RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.	Class II	Boston Scientific Corporation
Sep 16, 2020	Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport M...	The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle...	Class II	Merit Medical Systems, Inc.
Sep 16, 2020	Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Us...	The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle...	Class II	Merit Medical Systems, Inc.
Sep 16, 2020	MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F,...	The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample colle...	Class II	Merit Medical Systems, Inc.
Sep 15, 2020	3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to...	Corrosion could cause performance failures in the product.	Class II	3M Company - Health Care Business
Sep 15, 2020	Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage...	Corrosion could cause performance failures in the product.	Class II	3M Company - Health Care Business
Sep 15, 2020	3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b...	Corrosion could cause performance failures in the product.	Class II	3M Company - Health Care Business

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.