Browse Device Recalls
1,382 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,382 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 1,382 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Feb 23, 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN):... | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the s... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 20, 2026 | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 13, 2026 | Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800... | units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable ... | Class II | Laerdal Medical Corporation |
| Dec 18, 2025 | Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Dec 18, 2025 | Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a g... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Dec 18, 2025 | Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered ... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Oct 6, 2025 | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... | A labeling error was identified on the affected product. The expiration date on the kit box label... | Class III | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P... |
| Aug 29, 2025 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound minia... | Production assembly error resulting in the potential for reversed articulation, where moving the ... | Class II | ImaCor Inc. |
| Aug 22, 2025 | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breath... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 22, 2025 | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 22, 2025 | MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. ... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 11, 2025 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109... | Potential for falsely depressed patient, quality control (QC), and/or calibration results or dela... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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 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 9, 2025 | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Conditio... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 20, 2025 | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | Potential contamination with small burrs, which if detach could be inhaled and result in potentia... | Class II | Intersurgical Inc |
| Jun 20, 2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | Potential contamination with small burrs, which if detach could be inhaled and result in potentia... | Class II | Intersurgical Inc |
| Jun 17, 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryng... | Potential for faulty devices as a result of depleted batteries. | Class I | Intersurgical Inc |
| Jun 16, 2025 | Biofinity Toric Multifocal Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | CooperVision, Inc. |
| Jun 16, 2025 | Biofinity XR Toric Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | CooperVision, Inc. |
| Jun 12, 2025 | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than exp... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 sli... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i SETpoint Calibrator | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 4, 2025 | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematol... | 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.