Browse Device Recalls
3,419 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,419 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 3,419 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2018 | Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use ... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 78148... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnos... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a ... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic devi... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems M... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Mod... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 16, 2018 | T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic devic... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America Corporation |
| Mar 14, 2018 | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen m... | After continuous operation for more than one and a half days, the image on the large screen monit... | Class II | Philips Electronics North America Corporation |
| Mar 13, 2018 | Genesis Surgical Cassette Tapered Implants are intended for placement fo... | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental bur... | Class II | Keystone Dental Inc |
| Mar 13, 2018 | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F ... | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, r... | Class II | Medtronic Vascular |
| Feb 26, 2018 | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. ... | Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a nee... | Class II | Beaver-Visitec International Inc. |
| 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 |
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.