Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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Date	Product	Reason	Class	Firm
Oct 8, 2014	Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform p...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform p...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Femoral Pack, catalog #900-2164 Used by medical staff to perform patient c...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perfor...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Cesarean Pack, Catalog number 900-403. Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perfor...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 7, 2014	Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: Th...	Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Sur...	Class II	Mortara Instrument, Inc
Oct 7, 2014	RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable i...	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.	Class II	Mako Surgical Corporation
Oct 7, 2014	The Persona Tibial Articular Surface Inserter is a sterilizable instrument in...	Affected product did not undergo heat treatment hardening step leading to the potential for defor...	Class II	Zimmer, Inc.
Oct 7, 2014	RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable ins...	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.	Class II	Mako Surgical Corporation
Oct 7, 2014	RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument de...	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.	Class II	Mako Surgical Corporation
Oct 7, 2014	Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske...	The product is non-sterile.	Class II	C.R. Bard, Inc.
Oct 6, 2014	LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Ente...	This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner...	Class II	Microbiologics Inc
Oct 6, 2014	Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters ...	Patients have experienced a bad taste associated with the filters.	Class II	Alliance Tech Medical, Inc
Oct 6, 2014	Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blanket...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) P...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes ...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes ...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Synthes Inflation System (03.804.4135) Product Usage: Inflation system i...	Additional instructions for use due to inability to raise the pressure above 10 atm during inflat...	Class II	PEROUSE MEDICAL
Oct 6, 2014	Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002X...	Stryker has received a complaint from customers relating to a fracture during the use of the Spec...	Class II	Stryker Spine
Oct 6, 2014	ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter...	Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce...	Class III	Siemens Healthcare Diagnostics, Inc
Oct 6, 2014	KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2...	This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner...	Class II	Microbiologics Inc
Oct 6, 2014	Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instru...	Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ...	Class II	Beckman Coulter Inc.
Oct 6, 2014	Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radi...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blanket...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Ra...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product U...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the...	Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monito...	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 6, 2014	Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Us...	Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ...	Class II	Beckman Coulter Inc.
Oct 6, 2014	Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Si...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	Laksell Gamma Knife Perfexion	Elekta has become aware that the latches may be locked before they have been fully turned resulti...	Class II	Elekta, Inc.
Oct 6, 2014	Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usa...	When not used correctly, Accusorb MRI products may overheat and lead to patient injury.	Class II	MWT Materials, Inc.
Oct 6, 2014	HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'...	There are additional and updated warning and cautions that are not in the Patient At-Home Guide f...	Class II	Baxter Healthcare Corp.
Oct 6, 2014	Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device i...	Additional instructions for use due to inability to raise the pressure above 10 atm during inflat...	Class II	PEROUSE MEDICAL
Oct 6, 2014	INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718...	The recalling firm received complaints related to leakage from the tubing near the white luer of ...	Class II	Alcon Research, Ltd.
Oct 6, 2014	KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (sin...	This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner...	Class II	Microbiologics Inc
Oct 6, 2014	UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand...	Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ...	Class II	Zimmer Surgical Inc
Oct 3, 2014	Philips Avalon Monitors with software revision J.30.58: Model Product F...	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB...	Class II	Philips Medical Systems, Inc.
Oct 3, 2014	OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to prov...	GE Healthcare initiated a field correction because prior revision of components were potentially ...	Class II	GE OEC Medical Systems, Inc
Oct 3, 2014	OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic an...	GE Healthcare initiated a field correction because prior revision of components were potentially ...	Class II	GE OEC Medical Systems, Inc
Oct 3, 2014	Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Mo...	Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NB...	Class II	Philips Medical Systems, Inc.
Oct 3, 2014	Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic a...	GE Healthcare initiated a field correction because prior revision of components were potentially ...	Class II	GE OEC Medical Systems, Inc
Oct 3, 2014	FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital M...	GE Healthcare initiated a field correction because prior revision of components were potentially ...	Class II	GE OEC Medical Systems, Inc
Oct 3, 2014	SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP4...	Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d...	Class II	Monteris Medical Corp
Oct 3, 2014	FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DT...	Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d...	Class II	Monteris Medical Corp
Oct 2, 2014	DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715	Particle residue on the instrument from adhesive tape which was used to bind the device during tr...	Class II	Synthes, Inc.
Oct 2, 2014	Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in ...	Failed to meet established requirements for sterile barrier integrity due to a breach of the inne...	Class II	Zimmer, Inc.
Oct 1, 2014	Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 6...	The affected products are missing polar boss threads.	Class II	Zimmer, Inc.
Oct 1, 2014	IMRIS Operating Room table (ORT200 and ORT300). Intended for use during di...	One of the three pins that is used to hold the ORT200 table alignment block in place on the floor...	Class II	IMRIS 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.