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 |
|---|---|---|---|---|
| Sep 11, 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, RE... | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D... | Class III | R & D Systems, Inc. |
| Aug 16, 2018 | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | There is a possibility that the product was packaged in the wrong box. Specifically, the product... | Class III | Collagen Matrix, Inc. |
| Aug 16, 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflec... | Class III | Medtronic Vascular |
| Aug 10, 2018 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CA... | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Class III | Medtest Holdings, Inc. |
| Aug 6, 2018 | Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monop... | The Manual cleaning process and the usability of the reprocessing instruction by the user had not... | Class III | Dannoritzer Medizintechnik GmbH & Co. KG |
| Aug 2, 2018 | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon... | The product is labeled with an incorrect expiration date. | Class III | Acumedia Manufacturers, Inc. |
| Aug 2, 2018 | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media... | Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe... | Class III | Acumedia Manufacturers, Inc. |
| Jul 13, 2018 | Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gase... | The product was mislabeled with the incorrect label. | Class III | Smiths Medical ASD Inc. |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... | The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and... | Class III | Ortho-Clinical Diagnostics |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 3, 2018 | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jul 3, 2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jun 22, 2018 | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: ... | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for u... | Class III | Clarity Diagnostics Llc |
| Jun 14, 2018 | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | Class III | Nidek Inc. |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III | Tosoh Bioscience Inc |
| Jun 4, 2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... | Mislabeled product | Class III | Richard-Allan Scientific Company |
| May 24, 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 23, 2018 | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 23, 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... | Through an investigation, it has been determined that vials of Collagen packaged within the Colla... | Class III | Helena Laboratories, Corp. |
| May 16, 2018 | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... | The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers... | Class III | Becton, Dickinson and Company, BD Biosciences |
| May 8, 2018 | Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: ... | Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. | Class III | Human Design Medical Llc |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 12, 2018 | Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 104... | Incorrect calibrator level listed in qualitative calibration steps | Class III | Siemens Healthcare Diagnostics, Inc. |
| Mar 2, 2018 | BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 | The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... | Class III | Becton Dickinson & Co. |
| Mar 2, 2018 | BD MAX DNA MMK Lab Use, catalog no. 442828 | The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... | Class III | Becton Dickinson & Co. |
| Feb 27, 2018 | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation a... | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended... | Class III | Helena Laboratories, Corp. |
| Feb 21, 2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III | CooperVision Inc. |
| Feb 16, 2018 | Strauss Penis Clamp 130MM/General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 16, 2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 13, 2018 | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Produ... | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob wil... | Class III | Michigan Instruments, Inc. |
| Feb 7, 2018 | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for us... | Update XL¿ device software to version A.03. This includes enhancements to the Operational Check... | Class III | Philips Electronics North America Corporation |
| Jan 11, 2018 | VITROS Immunodiagnostic Products TSH Reagent Pack | VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signa... | Class III | Clinical Diagnostic Systems |
| Jan 9, 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Us... | Product is labeled with "CE", but is not yet approved in the European Union. | Class III | Riverpoint Medical, LLC |
| Jan 5, 2018 | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use... | Contains a gel-like contaminant that may affect product performance. | Class III | Diamedix 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.