Browse Device Recalls
1,023 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,023 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 1,023 FDA device recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2023 | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... | Class III | Fresenius Medical Care Holdings, Inc. |
| Sep 25, 2023 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class III | Aizu Olympus Co., Ltd. |
| Aug 14, 2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... | Class III | Microbiologics Inc |
| Jul 25, 2023 | ZVU Functional GI Software, REF: ZVU-3 | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. | Class III | Diversatek Healthcare |
| May 18, 2023 | VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). | Class III | Ortho-Clinical Diagnostics, Inc. |
| May 15, 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... | Potential for lot number discrepancies between the test strip packaging and the barcode label app... | Class III | NeuMoDx Molecular Inc |
| May 4, 2023 | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... | Delay in reporting results due to Quality Controls running high outside of range. Target value an... | Class III | Randox Laboratories Ltd. |
| May 4, 2023 | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... | Delay in reporting results due to Quality Controls running high outside of range. Target value a... | Class III | Randox Laboratories Ltd. |
| May 4, 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc... | Class III | Datascope Corp. |
| Apr 24, 2023 | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower ... | Class III | Abbott Ireland Limited |
| Apr 17, 2023 | Total Knee Pack, REF CETJ130, medical convenience kits | Incorrect expiration date on product. | Class III | American Contract Systems, Inc. |
| Apr 14, 2023 | RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vit... | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... | Class III | Mechatronics USA |
| Apr 14, 2023 | RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagn... | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... | Class III | Mechatronics USA |
| Mar 31, 2023 | To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Mar 31, 2023 | ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endo... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Feb 17, 2023 | Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 | Distributed sample collection kit with an unapproved instruction for use. | Class III | AGILENT TECHNOLOGIES INC./US |
| Feb 1, 2023 | PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials... | Product is labeled with an incorrect expiration date. | Class III | Preat Corp |
| Jan 20, 2023 | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart R... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 20, 2023 | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart R... | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... | Class III | SUREPULSE MEDICAL LTD |
| Jan 5, 2023 | abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... | Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... | Class III | S & MOHR AMERICA, S.A. DE C.V. |
| Jan 3, 2023 | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... | Class III | Owens & Minor Distribution, Inc. |
| Dec 5, 2022 | Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 | mislabeled product | Class III | Young Dental Manufacturing I, LLC |
| Nov 24, 2022 | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... | Reaction vessels may contain a potential contaminant that could affect their optical performance. | Class III | Abbott Laboratories |
| Nov 7, 2022 | Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... | Class III | Howmedica Osteonics Corp. |
| Nov 7, 2022 | R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... | Class III | R & D Systems, Inc. |
| Nov 7, 2022 | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... | Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... | Class III | Howmedica Osteonics Corp. |
| Sep 23, 2022 | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers wer... | Class III | LumiraDx |
| Sep 2, 2022 | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... | Class III | Baxter Healthcare Corporation |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Aug 16, 2022 | PTS Panels CHOL+GLU Test Strips (REF 1765) | Incorrect instructions for use were packaged into the final product. | Class III | Polymer Technology Systems, Inc. dba PTS Diagno... |
| Aug 10, 2022 | Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... | Product contains incorrect chemical indicators in packaging. | Class III | Steris Corporation Hopkins Facility |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jul 12, 2022 | AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... | The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... | Class III | Siemens Medical Solutions USA, Inc |
| Jun 28, 2022 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Aniara Diagnostica LLC |
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... | Class III | Zeiss, Carl Inc |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... | Class III | R & D Systems, Inc. |
| Jun 10, 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... | Class III | Invacare Corporation |
| Jun 9, 2022 | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| Jun 9, 2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| May 31, 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... | Firm has revised labeling to consistently call out storage conditions and revised the instruction... | Class III | Synapse Biomedical Inc |
| May 31, 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not matc... | Class III | Boston Scientific Corporation |
| May 25, 2022 | a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
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.