Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 18, 2017 | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... | Class II | Bioseal Corporation |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 10, 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... | Class II | Medtronic Inc. |
| Oct 10, 2017 | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implan... | One reported complaint and discovered that the outer vial was out of round and undersized. There... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Oct 10, 2017 | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out... | The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo... | Class II | Karl Storz Endoscopy |
| Oct 9, 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10... | Cepheid has received reports that some of our customers have experienced a higher number of temp... | Class II | Cepheid |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Oct 2, 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor,... | Pre-procedural issues related to software defects | Class II | Edwards Lifesciences, LLC |
| Sep 30, 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... | Product was released to market without the adulteration strip included in the product. | Class III | Ameditech Inc |
| Sep 19, 2017 | daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitiv... | Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in ... | Class II | Intuitive Surgical, Inc. |
| Sep 15, 2017 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reve... | Customers have reported a higher than expected number of invalid test results when using the reca... | Class II | Cepheid |
| Sep 15, 2017 | Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In... | An incorrect incubator was installed on one Panther System which potentially led to incorrect Apt... | Class II | Hologic, Inc |
| Sep 13, 2017 | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... | It was determined that the deflection length indicated on the Guide catheter handle does not matc... | Class II | Medtronic Vascular, Inc. |
| Sep 12, 2017 | Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is ... | During an examination images were displayed on the live monitor,but the images were not displayed... | Class II | Toshiba American Medical Systems Inc |
| Sep 10, 2017 | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 10, 2017 | Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | Class II | Medtronic Inc. |
| Sep 7, 2017 | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood ga... | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give i... | Class II | Radiometer America Inc |
| Sep 6, 2017 | THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-13270... | Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... | Class II | Biosense Webster, Inc. |
| Sep 6, 2017 | THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-... | Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... | Class II | Biosense Webster, Inc. |
| Sep 6, 2017 | THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) | Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... | Class II | Biosense Webster, Inc. |
| Sep 6, 2017 | THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02... | Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... | Class II | Biosense Webster, Inc. |
| Sep 6, 2017 | THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S,... | Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... | Class II | Biosense Webster, Inc. |
| Sep 1, 2017 | AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500... | The recommended storage temperature on the label is incorrect. | Class II | Aaren Scientific Inc. |
| Aug 31, 2017 | SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... | ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... | Class II | ICU Medical, Inc. |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (L... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, P... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Acce... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber ... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merli... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models E... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 28, 2017 | PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devic... | New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... | Class II | St Jude Medical Inc. |
| Aug 24, 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter ... | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibra... | Class II | Beckman Coulter Inc. |
| Aug 21, 2017 | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended f... | Beckman Coulter has identified that an incorrect setting using a proprietary software configurati... | Class II | Beckman Coulter Inc. |
| Aug 9, 2017 | Alaris Pump Module model 8100 manufactured between November 2011 and March 20... | The recalling firm has received reports of increased or decreased flows that have occurred in cer... | Class II | CareFusion 303, Inc. |
| Aug 7, 2017 | MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref G... | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. | Class II | Microvention, Inc. |
| Aug 3, 2017 | Power Processor 1K Stockyard. The Power Processor performs all pre-analyti... | Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can ini... | Class II | Beckman Coulter Inc. |
| Jul 31, 2017 | 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Ro... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Sto... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, Inc. |
| Jul 31, 2017 | 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blo... | Some devices were labeled as Does not contain DEHP even though the product may contain small am... | Class II | ICU Medical, 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.