Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 5, 2018 | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ... | Contains a gel-like contaminant that may affect product performance. | Class III | Diamedix Corporation |
| Dec 21, 2017 | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetri... | The kits contained an incorrect lot of Dropper Plus Level 1 vials | Class III | Quantimetrix Corporation |
| Dec 20, 2017 | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370... | The controls and calibrators contained within the cocaine test kit may cause false positive resul... | Class III | OraSure Technologies, Inc. |
| Dec 19, 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p... | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 19, 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, S... | The product is labeled with the incorrect expiration date. | Class III | LivaNova USA |
| Dec 15, 2017 | Alere iScreen Dx Urine Drug Screen Card | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti... | Class III | Ameditech Inc |
| Dec 1, 2017 | Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa... | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket ... | Class III | Mindray DS USA, Inc. dba Mindray North America |
| Nov 28, 2017 | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/... | The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce value... | Class III | Alere San Diego Inc. DBA Immunalysis Corporation |
| Nov 22, 2017 | ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906,... | The incorrect IFU was shipped with the product. | Class III | ECOLAB INC |
| Nov 22, 2017 | ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905... | The incorrect IFU was shipped with the product. | Class III | ECOLAB INC |
| Nov 7, 2017 | T/Pump temperature therapy pump, Models TP700 and TP700C | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,... | Class III | Stryker Medical Division of Stryker Corporation |
| Nov 6, 2017 | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 6, 2017 | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 6, 2017 | Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Oct 29, 2017 | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use... | It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the f... | Class III | Xintec Corp |
| Oct 16, 2017 | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe... | A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in th... | Class III | Keystone Dental Inc |
| Oct 3, 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| 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 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r... | Class III | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 21, 2017 | Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692... | There is a possibility that specific lots of catheters that have recently been distributed may be... | Class III | Medtronic Neuromodulation |
| Sep 20, 2017 | Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar... | Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do... | Class III | Philips Electronics North America Corporation |
| Sep 1, 2017 | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com... | The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister la... | Class III | CooperVision Inc. |
| Aug 11, 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 11, 2017 | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison... | Class III | Ivoclar Vivadent, Inc. |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison... | Class III | Ivoclar Vivadent, Inc. |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison... | Class III | Ivoclar Vivadent, Inc. |
| Aug 3, 2017 | Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 | Complaints were filed claiming the material consistency was too soft and too sticky in comparison... | Class III | Ivoclar Vivadent, Inc. |
| Aug 2, 2017 | JANUS & JANUS G3 Automated Workstation is an automated programmable liquid h... | We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were... | Class III | Perkinelmer Life Sciences, Inc. |
| Jul 10, 2017 | VITROS Chemistry Products Performance Verifier is used as an assayed control ... | VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements fo... | Class III | Ortho Clinical Diagnostics Inc |
| Jul 10, 2017 | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to ... | Two specific lots was incorrectly manufactured containing a UK power adapter. | Class III | AMEDA, INC. |
| Jun 26, 2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl... | The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl... | Class III | Ameditech Inc |
| Jun 2, 2017 | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | Label on product box contains the incorrect reference #317-09 while the shelf box label with barc... | Class III | C.R. Bard, Inc. |
| Jun 1, 2017 | BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is desi... | Potential unexpected movement of robot arm | Class III | Becton Dickinson & Co. |
| May 31, 2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... | Class III | PerkinElmer Health Sciences, Inc. |
| May 22, 2017 | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-... | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit b... | Class III | Euro Diagnostica AB |
| May 8, 2017 | Beekley Medical 0-SPOT Mammography Skin Markers REF 652 | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels | Class III | Beekley Corporation |
| Apr 27, 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control m... | According to Randox Laboratories an investigation indicates a labelling error for 2 of the test m... | Class III | Randox Laboratories |
| Mar 29, 2017 | Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. | Some of the individual unit packaging (pouches) may be missing the lot number an expiration date. | Class III | Teleflex Medical |
| Mar 2, 2017 | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Mar 2, 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Feb 24, 2017 | BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class III | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: ... | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 8, 2017 | AIA-PACK TPOAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Feb 8, 2017 | AIA-PACK TgAb CONTROL SET | The label contains two different methodologies. Quality Control values for non-FDA approved metho... | Class III | Tosoh Bioscience, Inc. |
| Jan 30, 2017 | Daavlin Aquex (DAAV1000) | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | Hidrex USA DVP1000 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 30, 2017 | Hidrex USA DP450 | The device was reclassified from a class III device to a class II device and there are new docume... | Class III | Hidrex GmbH |
| Jan 25, 2017 | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Jan 25, 2017 | The UNI-CP System; Model Number: 330230SND. | The firm received one complaint from one non-US sales representative (France) that the label on t... | Class III | Integra LifeSciences Corp. |
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.