Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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Date	Product	Reason	Class	Firm
Oct 18, 2018	iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. T...	Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitiv...	Class II	Beckman Coulter Inc.
Oct 17, 2018	NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Us...	Instructions for Use booklets were not included on the outer pouch	Class II	Numed Inc
Oct 17, 2018	NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Us...	Instructions for Use booklets were not included on the outer pouch	Class II	Numed Inc
Oct 17, 2018	Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0...	Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to...	Class II	Volcano Corporation
Oct 17, 2018	Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0...	Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to...	Class II	Volcano Corporation
Oct 17, 2018	NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Elec...	An intermittent failure which causes a blender initialization fault upon start-up or during an EP...	Class II	Terumo Cardiovascular Systems Corporation
Oct 17, 2018	NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-...	A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack...	Class II	Leoni Fiber Optics GmbH
Oct 17, 2018	NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ...	There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally rel...	Class II	Richard Wolf GmbH
Oct 17, 2018	Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-...	A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack...	Class II	Leoni Fiber Optics GmbH
Oct 17, 2018	Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-...	A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack...	Class II	Leoni Fiber Optics GmbH
Oct 17, 2018	Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve S...	A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack...	Class II	Leoni Fiber Optics GmbH
Oct 17, 2018	NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis ...	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause...	Class II	NxStage Medical, Inc.
Oct 17, 2018	Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Ste...	A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken pack...	Class II	Leoni Fiber Optics GmbH
Oct 16, 2018	(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018	Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx....	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	MED EL Cochlear Implant System, SONATATIi100, sold under the following implan...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018	BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL ...	specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 16, 2018	Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 16, 2018	Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, ble...	Potential that gauze pads may not be fully sterilized	Class II	ASO, LLC
Oct 16, 2018	Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number H...	The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a...	Class II	Conformis, Inc.
Oct 16, 2018	Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE ...	Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration d...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Oct 16, 2018	Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo...	Devices were distributed despite the Helium-fine leak test results not being within the cochlear ...	Class II	MED-EL Elektromedizinische Gereate, Gmbh
Oct 16, 2018	(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX E...	Under certain fault conditions, the existing design may expose the operator to a hazardous voltag...	Class II	Carl Zeiss Meditec, Inc.
Oct 16, 2018	Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version...	software malfunction; It was found when a user performs radiography using the wireless flat pane...	Class II	Canon Medical System, USA, INC.
Oct 16, 2018	Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 16, 2018	Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende...	Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v....	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 16, 2018	(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig...	The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri...	Class II	Argon Medical Devices, Inc
Oct 15, 2018	Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software...	Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured p...	Class II	Smiths Medical ASD Inc.
Oct 15, 2018	Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, ...	There is a potential for the male connectors on external cables to become damaged. This could inc...	Class II	Jarvik Heart Inc
Oct 12, 2018	ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR pla...	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du...	Class II	Abbott Ireland Diagnostics Division
Oct 12, 2018	ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR plat...	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du...	Class II	Abbott Ireland Diagnostics Division
Oct 12, 2018	Zimmer Compress Devices and Instruments: Item Number/Item Description 17835...	Correction to update the surgical technique for the Compress System. To make users aware of the c...	Class II	Zimmer Biomet, Inc.
Oct 12, 2018	Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128	This recall has been initiated in response to a seal defect found in certain sterile barrier pouc...	Class II	Atrium Medical Corporation
Oct 11, 2018	Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical im...	Synchronization failure	Class II	GE Healthcare, LLC
Oct 11, 2018	Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundatio...	Synchronization failure	Class II	GE Healthcare, LLC
Oct 11, 2018	St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6...	The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w...	Class II	St. Jude Medical, Inc.
Oct 11, 2018	Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vit...	Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) ma...	Class II	Siemens Healthcare Diagnostics, Inc.

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.