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 |
|---|---|---|---|---|
| Aug 8, 2016 | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 6... | There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 wher... | Class II | Beckman Coulter Inc. |
| Aug 8, 2016 | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: Th... | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis ... | Class II | Nidek Inc |
| Aug 5, 2016 | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... | Class II | Medtronic Inc. |
| Aug 4, 2016 | AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C i... | Belt clip may become detached causing electronic components to be exposed. | Class II | AirStrip Technologies, Inc. |
| Aug 4, 2016 | Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultras... | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System beca... | Class II | Toshiba American Medical Systems Inc |
| Aug 4, 2016 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7... | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t... | Class II | Beckman Coulter Inc. |
| Aug 3, 2016 | Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-... | Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | Class III | Alere San Diego, Inc. |
| Jul 25, 2016 | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI ... | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than t... | Class II | Microgenics Corporation |
| Jul 20, 2016 | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instruc... | Incorrect drill protocol in the Instructions for Use (IFU) | Class II | Nobel Biocare Usa Llc |
| Jul 19, 2016 | Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 ... | Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software ver... | Class II | Thermo Finnigan LLC |
| Jul 18, 2016 | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... | Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jul 18, 2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert... | Internal investigation found the certain lots of MRSA kits have the potential for performance iss... | Class II | Cepheid |
| Jul 15, 2016 | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The syste... | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration proc... | Class II | Topcon Medical Laser Systems, Inc |
| Jul 14, 2016 | STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Int... | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... | Class II | Intuitive Surgical, Inc. |
| Jul 14, 2016 | CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Sur... | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... | Class II | Intuitive Surgical, Inc. |
| Jul 14, 2016 | CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urolo... | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... | Class II | Intuitive Surgical, Inc. |
| Jul 14, 2016 | STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The ... | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... | Class II | Intuitive Surgical, Inc. |
| Jul 14, 2016 | STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Int... | Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and ... | Class II | Intuitive Surgical, Inc. |
| Jul 14, 2016 | STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intu... | An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced... | Class II | Intuitive Surgical, Inc. |
| Jul 13, 2016 | 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usa... | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/pa... | Class II | AccessClosure, Inc., A Cardinal Health Company |
| Jul 12, 2016 | Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with... | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain... | Class II | Resmed Corporation |
| Jul 11, 2016 | Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 ... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Pr... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRa... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 P... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number ... | The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may ... | Class II | American National Mfg Inc |
| Jul 11, 2016 | Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Str... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A ... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 11, 2016 | Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... | Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... | Class I | Alere San Diego, Inc. |
| Jul 5, 2016 | RePlant¿ Angled Abutment Part Number 6050-52-60 | Issue with design specification; oversized condition. | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jul 5, 2016 | AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The Amed... | Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may e... | Class III | Branan Medical Corporation |
| Jul 1, 2016 | OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... | Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... | Class II | Nidek Inc |
| Jul 1, 2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 serie... | There is an observed failure of the backrest bracket which can fatigue over the life time of the ... | Class II | Sunrise Medical (US) LLC |
| Jun 27, 2016 | The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel Dx... | Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and th... | Class II | Beckman Coulter Inc. |
| Jun 24, 2016 | BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tub... | One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to a... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jun 24, 2016 | Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a sing... | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year... | Class II | Danville Materials, Inc. |
| Jun 23, 2016 | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60... | Incorrect CO2 readings with some patient monitors. | Class II | Edan Diagnostics |
| Jun 23, 2016 | Optical Surface Monitoring System{Align RT Plus} This is used on Varian's Tru... | Varian Medical Systems has received reports that unintended changes were made to planned couch p... | Class II | Varian Medical Systems, Inc. |
| Jun 23, 2016 | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on... | Varian Medical Systems has received reports that unintended changes were made to planned couch pa... | Class II | Varian Medical Systems, Inc. |
| Jun 22, 2016 | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... | Incorrect top label on an implant package. | Class II | Nobel Biocare Usa Llc |
| Jun 22, 2016 | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, 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.