Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 25, 2025 | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821... | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or other... | Class II | Merit Medical Systems, Inc. |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Softwa... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan pan... | Due to the likely presence of contamination in well(s). | Class II | Beckman Coulter, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Cat... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catal... | The defect in the thread area will not allow the device to fully engage with an implant or analog... | Class II | Dentsply IH, Inc. |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Sof... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 24, 2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Numbe... | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side o... | Class II | THOR Photomedicine Ltd |
| Jul 23, 2025 | Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... | Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 22, 2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... | The potential for unsterilized product within finished product labeled as sterile. | Class II | LUMENIS, LTD. |
| Jul 22, 2025 | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X1100... | Due to incorrect software configuration that potentially allows more than two (2) fractions withi... | Class II | Reflexion Medical, Inc. |
| Jul 22, 2025 | LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-0000... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-00195... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434... | Due to required inspections not being performed on products/units that have gone through servicing. | Class II | Physio-Control, Inc. |
| Jul 22, 2025 | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitr... | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain p... | Class II | Trinity Biotech USA |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The ST... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Mode... | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. | Class II | B.Braun Medical S.A.S. |
| Jul 21, 2025 | Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Ballo... | Potential for the balloon in the device to not meet burst specifications. | Class II | SUMMA THERAPEUTICS, LLC |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 19, 2025 | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit M... | Device contains indications for use and device compatibility claims that have not be reviewed and... | Class II | Insightra Medical Inc |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 17, 2025 | Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant ... | Measles IgM Test Kit lacks premarket approval or clearance. | Class II | Quest International, Inc. |
| Jul 17, 2025 | SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Fol... | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jul 17, 2025 | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley ... | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jul 17, 2025 | Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software | Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculati... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 17, 2025 | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Mode... | Surgical drape packs may have open seals, which may compromise the sterility of the product. | Class II | O&M HALYARD INC |
| Jul 17, 2025 | SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... | Class II | C.R. Bard Inc |
| Jul 17, 2025 | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. ... | Due to out of the box wobble of the driver. | Class II | Medtronic Xomed, Inc. |
| Jul 16, 2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c serie... | Class II | Pentax of America Inc |
| Jul 16, 2025 | Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Ti... | The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. Wh... | Class II | Dynex Technologies, Inc. |
| Jul 16, 2025 | TOPS Inserter, part of the TOPS System Instrument Set used for implantation o... | Potential for missing pins at tip of inserter. | Class II | PREMIA SPINE LTD |
| Jul 15, 2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 15, 2025 | Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade... | Surgical lights have stress lines forming on the powder coating, which indicates that powder coat... | Class II | Stryker Communications |
| Jul 15, 2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | 3mensio Workstation (Vascular Fenestrated) software | When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (i... | Class II | PIE Medical Imaging B.V. |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems Inc |
| Jul 14, 2025 | Spectrum IQ Infusion Pump, Product Code 3570009 | Baxter has identified that certain pumps have potentially been released with the grease applied t... | Class II | Baxter Healthcare Corporation |
| Jul 14, 2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... | During an internal investigation, ACS determined that the rationale for sterilization of certain ... | Class II | American Contract Systems 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.