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 |
|---|---|---|---|---|
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| 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 |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Jan 30, 2023 | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test fo... | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Contr... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 30, 2023 | Fusion Bioline Vascular Graft, Part number M00201503046B0 | One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness test... | Class II | Maquet Cardiovascular, LLC |
| Jan 30, 2023 | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Jan 30, 2023 | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog ... | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of th... | Class II | Carefusion 2200 Inc |
| Jan 30, 2023 | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;... | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... | Class II | DiaSorin Molecular LLC |
| Jan 30, 2023 | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For ... | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead ... | Class II | Carestream Health, Inc. |
| Jan 27, 2023 | Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative dete... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH Total Protein II- In vitro diagnostic use in the quantitative det... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative de... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quant... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 26, 2023 | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2... | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increas... | Class II | Beckman Coulter, Inc. |
| Jan 26, 2023 | Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (e... | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... | Class II | CooperVision, Inc. |
| Jan 26, 2023 | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... | Class II | CooperVision, Inc. |
| Jan 25, 2023 | Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of ind... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 25, 2023 | Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilator... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventila... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 25, 2023 | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT | Affected lots have the potential for a broken sled vane, which may cause the reload to misfire le... | Class II | Covidien, LP |
| Jan 25, 2023 | Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the ... | Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output... | Class II | Stryker Corporation |
| Jan 25, 2023 | Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventil... | There is the potential for patient desaturation events to occur under certain scenarios when the ... | Class I | Baxter Healthcare Corporation |
| Jan 25, 2023 | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt ... | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in... | Class II | Limacorporate S.p.A |
| Jan 25, 2023 | Easy Read App associated with First Response Pregnancy Test Sticks - Intende... | Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 5... | Class II | Church & Dwight Inc |
| Jan 24, 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a ne... | An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of i... | Class II | Outset Medical, Inc. |
| Jan 24, 2023 | Patient Side Cart, REF: 380620, with instrument arms, used as part of the da ... | Preventative maintenance data was used to identify instrument Arms, part of surgical systems, tha... | Class II | Intuitive Surgical, Inc. |
| Jan 24, 2023 | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car... | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con... | Class II | CareFusion 303, Inc. |
| Jan 23, 2023 | NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S)... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| Jan 23, 2023 | NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| 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 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 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 | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious... | Screw connection between the turbine head and the push button may loosen and fall off during the ... | Class II | Coltene Whaledent Inc |
| Jan 20, 2023 | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... | Class II | Medtronic Neuromodulation |
| 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 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 18, 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an... | Class II | Philips North America |
| Jan 18, 2023 | Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1. | Labeling being updated to assure user is securing the siderail to a locked position to prevent po... | Class II | Linet Spol. S.r.o. |
| Jan 16, 2023 | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3... | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. | Class II | Fujifilm Irvine Scientific, Inc. |
| Jan 16, 2023 | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-... | C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual | Class II | Hologic, Inc. |
| Jan 13, 2023 | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. | Sterile product pouches were not sealed. | Class II | Summit Medical, LLC |
| Jan 11, 2023 | Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- ... | Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, a... | Class II | Covidien, LP |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, 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.