Browse Device Recalls
34,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,057 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 34,057 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagn... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | DEXLOCK Achilles Repair Implant Kits, MAKT4520 | There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill gu... | Class II | Medline Industries, LP |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and t... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and tre... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. R... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic appl... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gyne... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for ur... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treat... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 10, 2025 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,... | The device has been delivered with a preassembled locking screw that had been inserted from the w... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Nov 10, 2025 | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For us... | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts... | Class II | Beckman Coulter, Inc. |
| Nov 7, 2025 | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin... | Due to a software implementation error that allowed instruments arms failing an important diagnos... | Class II | Intuitive Surgical, Inc. |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to proc... | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing d... | Class II | Beckman Coulter, Inc. |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar... | Due to a number of modules flashed with a date and time associated with the daylight savings time... | Class II | CareFusion 303, Inc. |
| Nov 6, 2025 | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, | Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration pr... | Class II | Bard Peripheral Vascular Inc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) | Following a component change in the DPOAE probe (speaker replacement), technical distortions may ... | Class II | PATH |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be ... | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign obje... | Class II | Accriva Diagnostics, Inc. |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for B... | Safety and efficacy of dialysis acid concentrate cannot be assured | Class II | Diasol, Inc |
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Cepheid |
| Nov 4, 2025 | Cardiosave Hybrid. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce... | Class II | Datascope Corp. |
| Nov 4, 2025 | Cardiosave Rescue. Intra-Aortic Balloon Pump system. | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce... | Class II | Datascope Corp. |
| Nov 3, 2025 | SQ40S Blood Transfusion Filter | Due to products being released for distribution prior to completion of the required quality contr... | Class II | GVS TM, Inc |
| Nov 3, 2025 | Continuous Glucose Monitor (CGM) | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
| Nov 3, 2025 | Estrogen & Progesterone Test | Distribution without premarket approval/clearance. | Class II | GET TESTED INTERNATIONAL AB |
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.