Browse Device Recalls

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Feb 26, 2018 Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Numbe... Products were packaged with incorrect labeling, Class II Beaver-Visitec International Inc.
Feb 21, 2018 Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS188... The invasive pressure visual and audible alarms may not activate. Class II Draegar Medical Systems, Inc.
Feb 21, 2018 ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 test... Upon dilution, some patient samples may exhibit over-recovery outside the representative data pro... Class II Siemens Healthcare Diagnostics, Inc
Feb 21, 2018 F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table ... The recalling firm has become aware that the rail section clamps used to attach the leg support o... Class II Allen Medical Systems
Feb 12, 2018 Capio RP; Model #M0068321010. Intended for use in general suturing applica... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use i... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in g... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue rei... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinfo... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue re... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue rei... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio CL; Model #M0068311350. Indicated for the placement of suture in a v... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tiss... Class II Boston Scientific Corporation
Feb 12, 2018 Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use ... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 12, 2018 Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturin... Potential for Capio sutures to break and /or detach. Class II Boston Scientific Corporation
Feb 7, 2018 GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter Syste... RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will resu... Class II Advanced Instruments, LLC
Feb 7, 2018 HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us... Update XL¿ device software to version A.03. This includes enhancements to the Operational Check... Class III Philips Electronics North America Corporation
Jan 29, 2018 NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M5... May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard d... Class II NxStage Medical, Inc.
Jan 29, 2018 Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America Corporation
Jan 29, 2018 Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter i... Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform use... Class II Philips Electronics North America Corporation
Jan 25, 2018 O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili... Class II Medtronic Navigation, Inc.-Littleton
Jan 24, 2018 Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usa... The recalling firm identified a software issue related to the Patient Line Check (PLC) which may ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jan 24, 2018 Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended... The cutting edge of tissue punches may be potentially damaged with small dents and nicks. Class II Keystone Dental Inc
Jan 12, 2018 Solid state x-ray imager (flat panel/digital imager) Solid state x-ray i... While transporting the portable machine with the retrofit equipment in a backwards motion, there ... Class II NeuroLogica Corporation
Jan 9, 2018 LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the q... The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause ... Class II Magellan Diagnostics, Inc.
Jan 9, 2018 LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P,... The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause th... Class II Magellan Diagnostics, Inc.
Jan 4, 2018 Allura Xper systems with Certeray X-ray Generator located in regions with hig... There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these produc... Class II Philips Electronics North America Corporation
Jan 3, 2018 Intellivue iX Information Center Software - All PIIC iX Surveillance stations... Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable ... Class II Philips Electronics North America Corporation
Dec 22, 2017 LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXP... Reports of product loosening or coming unscrewed from the handle. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Dec 20, 2017 Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: ... Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), mi... Class II Philips Electronics North America Corporation
Dec 20, 2017 SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 Certain lots of devices may have the working channel sleeve protruding from the camera cap which ... Class II Boston Scientific Corporation
Dec 18, 2017 Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukoc... Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduc... Class II Terumo Cardiovascular Systems Corp
Dec 15, 2017 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... Class II DePuy Spine, Inc.
Dec 14, 2017 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial... When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 12, 2017 Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 087147... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 12, 2017 Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 ... Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. Class II Boston Scientific Corporation
Dec 11, 2017 digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/... It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may ... Class II Philips Electronics North America Corporation
Dec 11, 2017 Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek ... Class II Smith & Nephew, Inc.
Dec 11, 2017 Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us... Contamination with Methylbacterium thiocyanatum Class II Sanofi Genzyme
Dec 8, 2017 Widefield OCT software feature for the Spectralis HRA+OCT and variants FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefiel... Class II Heidelberg Engineering
Nov 21, 2017 Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is mar... The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Li... Class II Medica Corporation
Nov 20, 2017 Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ... The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the ex... Class II OMNIlife science Inc.
Nov 17, 2017 IntelliVue X3 Patient Monitor. The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instea... Class II Philips Electronics North America Corporation
Nov 13, 2017 HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline co... A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection... Class II Lifeline Systems Company
Nov 10, 2017 NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStag... Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatme... Class II NxStage Medical, Inc.
Nov 9, 2017 ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: T... Certain catheters could have a compromised catheter shaft due to a manufacturing defect which cou... Class II Vascular Insights, LLC

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.