Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 19, 2019 | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 19, 2019 | Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm... | The product contains a misprinted expiration date on the peel pack. Both were printed as "180615... | Class III | Beaver Visitec |
| Feb 19, 2019 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... | Class II | Philips Medical Systems Nederlands |
| Feb 19, 2019 | smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZ... | Complaints were received indicating that the outer label incorrectly identified the product as si... | Class II | Smith & Nephew, Inc. |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous... | Breach in the sterile barrier pouch may compromise sterility of the device. | Class II | Avitus Orthopaedics, Inc. |
| Feb 18, 2019 | Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellou... | Breach in the sterile barrier pouch may compromise sterility of the device. | Class II | Avitus Orthopaedics, Inc. |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 18, 2019 | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCUL... | Certain product code/lot number combinations may experience introducer sheath compatibility issu... | Class II | Bard Peripheral Vascular Inc |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufacturer has found that ... | Class II | TeDan Surgical Innovations LLC |
| Feb 15, 2019 | QuickTox 5 Panel Drug Screen DipCard | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere... | Class III | Ameditech Inc |
| Feb 15, 2019 | Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosu... | Potential for the sterile packaging to be compromised | Class II | Covidien, PLC |
| Feb 15, 2019 | Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with ... | The polarity of the output of power supply was reversed. Due to polarity of the output of power... | Class II | Alere San Diego, Inc. |
| Feb 15, 2019 | Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736 | The product does not meet sterility requirements. Product labeled as sterile was distributed wit... | Class II | COVIDIEN LLC |
| Feb 14, 2019 | SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomograp... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-En... | Complaints received that products packaged with the incorrect introducer sheath size. | Class II | Bard Peripheral Vascular Inc |
| Feb 14, 2019 | SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed to... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomogra... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948... | The devices were released from a lot for which one sample failed to meet the company' s tensile s... | Class II | ACell, Inc |
| Feb 14, 2019 | Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948... | The devices were released from a lot for which one sample failed to meet the company' s tensile s... | Class II | ACell, Inc |
| Feb 14, 2019 | SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spira... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 13, 2019 | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality ... | An error in the assignment of the control range pH in Blood Gas Control | Class II | Randox Laboratories Ltd. |
| Feb 13, 2019 | BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device inten... | The firm became aware of the potential for the products' sterile pouch to be punctured during tra... | Class II | Bioventus, LLC |
| Feb 12, 2019 | Discovery IQ Product Usage: The systems are intended for head and whole b... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery PET/CT 710 Product Usage: The systems are intended for head and... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | e500 Automatic Transport Ventilator, Model Number 01EVE500 | There is a potential for the unit to catch fire due to one of the screen retaining screws being i... | Class I | O-Two Medical Technologies, Inc. |
| Feb 12, 2019 | e600 Automatic Transport Ventilator, Model Number 01EVE600 | There is a potential for the unit to catch fire due to one of the screen retaining screws being i... | Class I | O-Two Medical Technologies, Inc. |
| Feb 12, 2019 | Optima PET/CT 560, 560FX Product Usage: The systems are intended for head... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery PET/CT 610 Product Usage: The systems are intended for head and... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | e700 Automatic Transport Ventilator, Model Number 01EVE700 | There is a potential for the unit to catch fire due to one of the screen retaining screws being i... | Class I | O-Two Medical Technologies, Inc. |
| Feb 12, 2019 | Discovery Ml Product Usage: The systems are intended for head and whole ... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 12, 2019 | Discovery Ml DR Product Usage: The systems are intended for head and whol... | GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure | Class II | GE Healthcare, LLC |
| Feb 11, 2019 | Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx... | Incorrect needle length and gage. | Class II | Smiths Medical ASD Inc. |
| Feb 11, 2019 | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autot... | The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" d... | Class II | Fenwal Inc |
| Feb 11, 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes in... | Packaged with an incorrect size inner cannula. | Class II | Smiths Medical ASD Inc. |
| Feb 8, 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The ... | The integrity of the sterile grid packaging is potentially compromised. | Class II | Riverpoint Medical, LLC |
| Feb 8, 2019 | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omn... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Om... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Omega Systems These devices are intended to be used in the environment whe... | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... | Class II | Draegar Medical Systems, Inc. |
| Feb 8, 2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio... | Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled inc... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Feb 8, 2019 | Terumo Needle, 30G x 1/2", Product Code NN3013R | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Needle, 18G x 1", Product Code NN1825R | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Monaco Radiation Treatment Planning (RTP) System | If Improve Target Dose was chosen as an optimization model in a previous treatment session, Mon... | Class II | Elekta, Inc. |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical Corporation |
| Feb 8, 2019 | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Produ... | Table tilts without operator involvement as a result of liquid spilling into tilt console trigger... | Class II | Canon Medical System, USA, INC. |
| Feb 8, 2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | There is a potential for a loss of package integrity that may compromise the sterility of the pro... | Class II | Terumo Medical 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.