Browse Device Recalls
309 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 309 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 309 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 12, 2026 | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... | Class I | Insulet Corporation |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU ... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 0... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACC... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65C... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; A... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 03... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Marker... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Mar 3, 2026 | Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038... | The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... | Class II | Angiodynamics, Inc. |
| Oct 7, 2025 | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... | Class II | Trividia Health, Inc. |
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... | Due to an identified manufacturing defect involving coating material lifting within the catheter'... | Class I | BALT USA, LLC |
| Sep 4, 2025 | XERF EFFECTOR 60. Electrosurgical unit. | Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result... | Class II | Lutronic 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. |
| Jul 8, 2025 | The Medline General Surgery Tray is customized to meet requirements of the ho... | Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 1, 2025 | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside ... | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potentia... | Class II | North American Rescue LLC. |
| Apr 30, 2025 | Sample probe sucks a sample dispensed into a tube or cup and discharges the ... | A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S p... | Class II | Beckman Coulter Mishima K.K. |
| Apr 21, 2025 | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... | Class II | Becton Dickinson Infusion Therapy Systems, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Pol... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Implantable Venous Acces... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 21, 2024 | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi... | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, Inc. |
| Sep 24, 2024 | medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... | Class II | Smiths Medical ASD, 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.