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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 21, 2018 | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At... | Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product U... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Produ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Pro... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium pro... | A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an i... | Class II | Becton Dickinson & Co. |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential ... | Class II | DePuy Orthopaedics, Inc. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 1022011008... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), pro... | The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pum... | Class II | Baxter Healthcare Corporation |
| Jun 21, 2018 | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a... | Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jun 21, 2018 | Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product ... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Pr... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 1... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 21, 2018 | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101... | The catheters are suspected to contain defective sensors; if used, defective catheter will show l... | Class II | Degania Silicone, Ltd. |
| Jun 20, 2018 | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO... | Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it sh... | Class II | Espiner Medical Ltd |
| Jun 20, 2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... | Class I | Vyaire Medical |
| Jun 20, 2018 | Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14... | Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablati... | Class II | Boston Scientific Corporation |
| Jun 19, 2018 | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108... | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | Class II | Vascular Technology, Inc. |
| Jun 19, 2018 | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penet... | The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU... | Class II | LeMaitre Vascular, Inc. |
| Jun 19, 2018 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopi... | Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall w... | Class II | Stryker Sustainability Solutions |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... | Mislabeled hook pouch included a transport/storage label rather than the product label containin... | Class II | Nico Corp. |
| Jun 18, 2018 | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmi... | Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the ... | Class II | Beaver Visitec |
| Jun 18, 2018 | Connecting Bolt, Model 14-442093 | Product was manufactured from the incorrect material, which shows a potential decrease in the fat... | Class II | Zimmer Biomet, Inc. |
| Jun 18, 2018 | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise ... | There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece sepa... | Class II | Bovie Medical Corporation |
| Jun 18, 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... | A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... | Class I | Compass Health Brands (Corporate Office) |
| Jun 18, 2018 | Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging d... | The stainless steel belt which runs the length of the table underneath the tabletop is exposed wh... | Class II | Hitachi Medical Systems America Inc |
| Jun 15, 2018 | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... | There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... | Class II | Medline Industries Inc |
| Jun 15, 2018 | TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... | Class II | Shimadzu Medical Systems Usa Com |
| Jun 15, 2018 | Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number ... | Potential proplylene glycol contamination | Class II | Covidien LLC |
| Jun 14, 2018 | VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD5688219... | Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head det... | Class II | Maquet SAS |
| Jun 14, 2018 | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Ele... | Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (M... | Class II | Abbott Laboratories, Inc. |
| Jun 14, 2018 | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | Class III | Nidek Inc. |
| Jun 13, 2018 | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Us... | These devices have an incorrect specification against safety standard ISO61010-1. Should a single... | Class II | Leica Microsystems, 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.