Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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Date	Product	Reason	Class	Firm
Oct 5, 2016	Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designe...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Card...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. ...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Ca...	Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf...	Class II	Stryker Neurovascular
Oct 5, 2016	MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 5, 2016	OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is des...	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came...	Class II	Oscor, Inc.
Oct 4, 2016	Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ...	Potential contamination with B. cepacia.	Class I	Nurse Assist, Inc
Oct 4, 2016	Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 0452812...	Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quan...	Class II	Roche Diagnostics Operations, Inc.
Oct 4, 2016	Covidien Clearify Visualization System Item Code: 21-345 Intended to be us...	Product sterility is compromised due to breach of the sterile barrier	Class II	Medtronic
Oct 4, 2016	COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Ca...	.Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-qua...	Class II	Roche Diagnostics Operations, Inc.
Oct 4, 2016	Best Practices kits containing certain production lots of Clearify Visualizat...	Product sterility is compromised due to breach of the sterile barrier	Class II	Medtronic
Oct 4, 2016	FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed ...	Inpeco received several notifications from the field about burnt schuko sockets. The customers re...	Class II	Inpeco S.A.
Oct 3, 2016	Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a h...	Medtronic has identified an increased number of complaints from customers involving reports of Re...	Class II	Medtronic Neuromodulation
Oct 3, 2016	3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	Medtronic SynchroMed II Implantable Drug Infusion System. This system includ...	Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for th...	Class I	Medtronic Neuromodulation
Oct 3, 2016	3.0 mm Reaming Rod/950 mm, Sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical devic...	The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsig...	Class II	Medimaps Group
Oct 3, 2016	3.0 mm Guide Rod/950 mm with Smooth Tip, sterile	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 3, 2016	Extraction Hook - Sterile for TI Cannulated Nails	The peel pouches for the affected reaming rods and extraction hooks are delaminating.	Class II	Synthes (USA) Products LLC
Oct 1, 2016	4205 Journey Rolling Walker Product Usage: used to assist people in walking	Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black si...	Class II	Nova Ortho-Med Inc
Sep 30, 2016	PET Infusion Pump	The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet ...	Class II	Bayer Healthcare
Sep 30, 2016	Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecar...	GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field corre...	Class II	GF Health Products, Inc
Sep 29, 2016	Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Produ...	Added Instructions for Use: After application, inspect the Light Glove for barrier integrity	Class II	Covidien LLC
Sep 29, 2016	Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: ...	Failure of the Offset Cup Reamer Handle not engaging its mating components.	Class II	Mako Surgical Corporation
Sep 29, 2016	FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is inten...	A complaint was received on September 27th, 2016 at a medical center in Germany for delamination ...	Class I	SentreHeart Inc
Sep 29, 2016	FlexLab Automation Modules		Class II	Siemens Healthcare Diagnostics, Inc.
Sep 29, 2016	Covidien Devon Light Glove packaged in sterile surgical kits Reference: 3114...	Added Instructions for Use: After application, inspect the Light Glove for barrier integrity	Class II	Covidien LLC
Sep 29, 2016	The ORCHESTRA Programmer A portable device, equipped with a microprocesso...	Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHEST...	Class II	Sorin Group USA, Inc.
Sep 29, 2016	8500M Handheld Pulse Oximeter	Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature...	Class II	Nonin Medical, Inc
Sep 29, 2016	Monaco RTP System The Monaco system is used to make treatment plans for pati...	When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician...	Class II	Elekta, Inc.
Sep 29, 2016	Aptio Automation Modules	Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 29, 2016	Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 1...	The insert and case label description of the device incorrectly reads Counter Incrementing Actuat...	Class II	Thayer Medical Corporation
Sep 29, 2016	Professional Hospital Supply, Inc Custom Packaging containing the Devon Light...	Added Instructions for Use: After application, inspect the Light Glove for barrier integrity	Class II	Covidien LLC
Sep 29, 2016	The ORCHESTRA PLUS Programmer A portable device, equipped with a micropro...	Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHEST...	Class II	Sorin Group USA, Inc.
Sep 28, 2016	ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catal...	Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha...	Class III	Angiodynamics, Inc.
Sep 28, 2016	Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to...	Class II	Baxter Healthcare Corp.
Sep 28, 2016	sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to...	Class II	Baxter Healthcare Corp.
Sep 28, 2016	V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S...	A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca...	Class II	Baxter Healthcare Corp.
Sep 28, 2016	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F ...	Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha...	Class III	Angiodynamics, Inc.
Sep 28, 2016	Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece	Complaints have been reported that the handpiece is inoperable. The investigation found that the ...	Class II	Zimmer Biomet, Inc.
Sep 28, 2016	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ...	Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha...	Class III	Angiodynamics, Inc.
Sep 28, 2016	ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F ...	Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined tha...	Class II	Angiodynamics, 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.