Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 11, 2023 | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... | Class I | Medtronic Navigation, Inc. |
| Apr 11, 2023 | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM;... | Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter a... | Class II | Bard Peripheral Vascular Inc |
| Apr 10, 2023 | Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062 | In the remote occurrence in which the electrical contactor component present in the drying chambe... | Class II | Steris Corporation |
| Apr 10, 2023 | Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... | The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reli... | Class II | Keystone Industries |
| Apr 10, 2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization... | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... | Class II | Wright Medical Technology, Inc. |
| Apr 10, 2023 | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization... | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked o... | Class II | Wright Medical Technology, Inc. |
| Apr 10, 2023 | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... | Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Apr 7, 2023 | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring Sys... | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially lea... | Class II | Cytrellis Biosystems, Inc. |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... | There were reports from customers that the tracheostomy in the sets and trays is not making a sec... | Class I | Cook Incorporated |
| Apr 7, 2023 | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... | There were reports from customers that the tracheostomy in the sets and trays is not making a sec... | Class I | Cook Incorporated |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... | Class II | 3M Company - Health Care Business |
| Apr 6, 2023 | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient ... | There is a low possibility that an electrical connector in the MR gradient coil will overheat on ... | Class II | Elekta, Inc. |
| Apr 6, 2023 | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intende... | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.... | Class II | Hiossen Inc. |
| Apr 6, 2023 | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... | Inadvertently released for distibution without sterility assurance. | Class II | Cardinal Health 200, LLC |
| Apr 6, 2023 | Fisher Wallace Stimulator Models FW-100 and FW-200 | If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, d... | Class II | Fisher Wallace Laboratories Inc. |
| Apr 6, 2023 | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... | Metal sterilization trays used to encase and protect medical devices during sterilization have a ... | Class II | Karl Storz Endoscopy |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243B | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... | Class II | 3M Company - Health Care Business |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pedia... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagn... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and puls... | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity ... | Class II | Draeger Medical Systems, Inc. |
| Apr 5, 2023 | ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra... | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product ... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... | Due to an automated dispensing cabinet software issue, when a medication single order contains mo... | Class II | CareFusion 303, Inc. |
| Apr 5, 2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Apr 5, 2023 | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... | Plastic sterilization trays used to encase and protect medical devices during sterilization have ... | Class II | Karl Storz Endoscopy |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calib... | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 5, 2023 | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL | There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... | Class II | Beckman Coulter Inc. |
| Apr 5, 2023 | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code... | DuraLife devices instructions for cleaning and sterilization have been determined to be inadequat... | Class II | Smiths Medical ASD Inc. |
| Apr 5, 2023 | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C1068... | Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 5, 2023 | WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H749... | The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... | Class II | Boston Scientific Corporation |
| Apr 5, 2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS... | Cybersecurity vulnerability concerning the software used for sequencing instruments. | Class II | Illumina, Inc. |
| Apr 5, 2023 | WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H749393... | The firm received complaints of the Insertion Tool component being occluded, resulting in the ina... | Class II | Boston Scientific Corporation |
| Apr 5, 2023 | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diag... | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sa... | Class II | Beckman Coulter, Inc. |
| Apr 4, 2023 | GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1s... | Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm ... | Class II | GRAMERCY EXTREMITY ORTHOPEDICS |
| Apr 4, 2023 | MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompati... | Class II | Datascope Corp. |
| Mar 31, 2023 | greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, no... | Some of the tubes may be incorrectly labeled. | Class II | Greiner Bio-One North America, Inc. |
| Mar 31, 2023 | Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) ... | There is a potential for mattress cover damage (delamination) which may result in fluid absorptio... | Class II | Baxter Healthcare Corporation |
| Mar 31, 2023 | ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device | In some cases the communication isolator installed in the Model 52X can cause a disturbance in th... | Class II | J&T Health and Wellness LLC |
| 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 |
| Mar 31, 2023 | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... | The liquid buffer component in the affected test kit lots was determined to have bacterial contam... | Class I | SD Biosensor, Inc. |
| Mar 31, 2023 | PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3... | Suture breakage during intra-operative use could result in poor performance of the impacted produ... | Class II | Ethicon, Inc. |
| Mar 30, 2023 | Medicine Dropper, Product Code K508 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| Mar 30, 2023 | Eye and Ear Dropper, Product Code 67082 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Apothecary Products, LLC |
| Mar 29, 2023 | binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Ch... | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis ... | Class II | Binx Health, 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.