Browse Device Recalls
34,198 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,198 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 34,198 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2025 | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... | Class II | Boston Scientific Corporation |
| Aug 4, 2025 | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, ... | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, lea... | Class II | Merit Medical Systems, Inc. |
| Aug 4, 2025 | Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Aug 4, 2025 | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Modul... | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously w... | Class II | Beckman Coulter Inc. |
| Aug 4, 2025 | Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Aug 4, 2025 | Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Mo... | Two new potential laser safety failure modes have been identified in the product design. Overcurr... | Class II | WASATCH PHOTONICS |
| Aug 1, 2025 | Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... | Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 1, 2025 | Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 31, 2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/Ti... | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security ... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 31, 2025 | Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Nam... | The potential of the elastic bands included in the kit detaching or fracturing during surgical pr... | Class II | Lumicell, Inc. |
| Jul 30, 2025 | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... | Units may have been packaged with an incorrect pouch label, which lists the reference number and ... | Class II | Contract Medical International GmbH |
| Jul 30, 2025 | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... | Dental implants were imported under temperature and storage conditions that do not comply with th... | Class II | S.I.N. Implant System Ltda |
| Jul 30, 2025 | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Num... | Due to a classification error in the inventory management system, specific medical devices were s... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jul 29, 2025 | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contai... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 29, 2025 | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit =... | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencin... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 28, 2025 | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model... | Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. | Class II | ORTOMA AB |
| Jul 28, 2025 | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... | Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, ... | Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air De... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| 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 25, 2025 | ZAP-X Radiosurgery System, Model: 300150 | If the radiosurgery system triggers a proximity error message during a long gantry move (greater-... | Class II | Zap Surgical Systems |
| Jul 25, 2025 | Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Gen... | Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Er... | Class II | Olympus Corporation of the Americas |
| 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: 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 | 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: 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 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 | 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 | 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 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 | 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 | 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 | 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 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 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 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 | 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 |
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.