Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2017 | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is... | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during... | Class II | Physio-Control, Inc. |
| Jan 14, 2017 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... | Indications for use are not cleared or approved for market in the U.S. | Class II | Med-Hot Thermal Imaging, Inc. |
| Jan 13, 2017 | Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: ... | Distribution of unapproved devices with incorrect air compression level setup | Class II | Won Industry Co. |
| Jan 13, 2017 | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | The product has the potential to be non-sterile as it was not packaged in accordance to specifica... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jan 13, 2017 | InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction ... | Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfus... | Class II | Vertebral Technologies, Inc. |
| Jan 13, 2017 | Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130... | Labeling error | Class II | Teleflex Medical |
| Jan 13, 2017 | Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air ... | Distribution of unapproved devices with incorrect air compression level setup | Class II | Won Industry Co. |
| Jan 13, 2017 | The LIFEPAK 1000 defibrillator is intended for use by personnel who are autho... | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off... | Class I | Physio-Control, Inc. |
| Jan 12, 2017 | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monit... | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer b... | Class I | Physio-Control, Inc. |
| Jan 12, 2017 | Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. | There is a potential for radio frequency (RF) interference to alter wireless communication from a... | Class II | Boston Scientific Corporation |
| Jan 12, 2017 | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. ... | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf lif... | Class II | Vascular Solutions, Inc. |
| Jan 12, 2017 | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019... | The firm received a complaint alleging that a DRX Revolution System could not be stopped when app... | Class II | Carestream Health Inc |
| Jan 11, 2017 | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... | Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... | Class II | Ortho Kinematics, Inc |
| Jan 11, 2017 | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usag... | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OP... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 11, 2017 | Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Stem Pack, part number AMS5166 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Hernia Pack, part number AMS3859 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | VIDAS 3 software v. 1.1.4 | During development of the VIDAS 3 software version 1.2, some anomalies have been identified and o... | Class II | BioMerieux SA |
| Jan 11, 2017 | Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Bayview Abdominoplasty Pack, part number 009079-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lower Extremity Pack, part number AMS4669 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lap Gallbladder Pack, part number AMS3707 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Plastic Pack, part number AMS3327(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Universal Pack, part number AMS2036 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Morris Lap Pack, part number PSS3199(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Angio Pack, part number AMS6711 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Vascular catheter introduction kit The PICC is indicated for short or long t... | There have been complaints for peel away sheaths flaring | Class II | Arrow International Inc |
| Jan 11, 2017 | Brow Pack, part number PSS1785(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Extremity Pack-N Brunswick, part number PSS1866(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic General Pack, part number AMS4215 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Pack , part number AMS6501 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr Bragg Vein Tray - RX, part number 007912-8 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Kit, part number CMP1084(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AM... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Pack (1185), part number AMS6560 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part n... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Set Up Pack, part number PSS3574(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Peri GYN, part number PSS2193(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | GYN Lap Pack, part number PSS2194(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Custom Breast Augmentation Pack, part number PSS2455(D | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Total Joint Pack, part number 006358-6 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Pod... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Head Pack, part number PSS1934(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Surgery Pack, part number AMS5685 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, 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.