Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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: 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 | 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 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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. |
| 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 |
| 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 | 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 | 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 | 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 | 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 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 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. |
| Mar 28, 2023 | Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-... | GE HealthCare has become aware of an issue where information from two different patients can be m... | Class II | GE Healthcare |
| Mar 28, 2023 | Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog ... | GE HealthCare has become aware of an issue where information from two different patients can be m... | Class II | GE Healthcare |
| Mar 28, 2023 | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 28, 2023 | Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2... | GE HealthCare has become aware of an issue where information from two different patients can be m... | Class II | GE Healthcare |
| Mar 28, 2023 | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 28, 2023 | DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs | The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration da... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 27, 2023 | Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended f... | Marketed without a 510k | Class II | IMMUNDIAGNOSTIK, Inc |
| Mar 27, 2023 | GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: ... | The product is brittle and potentially crumbling upon handling or when being removed from its pac... | Class II | Baxter Healthcare Corporation |
| Mar 27, 2023 | TDHisto/Cyto - A software product used for managing medical information in th... | In a specific use case, when printing labels for slides, some labels may display wrong information | Class II | Technidata S.A. |
| Mar 27, 2023 | Omnicell IVX Station-For use in the automated preparation of pharmaceutical a... | IVX Station does not account for inherent scale inaccuracy or variability, could result in a prep... | Class II | OmniCell, Inc. |
| Mar 27, 2023 | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM | A mispack occurred during the manufacturing process, resulting in the box incorrectly containing ... | Class II | Smith & Nephew, Inc. |
| Mar 24, 2023 | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 | Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If,... | Class II | Richard Wolf GmbH |
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.