Browse Device Recalls
1,398 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,398 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 1,398 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2026 | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# C... | Suture anchor may contain incorrect patient implant card which may result in incorrect device ide... | Class II | ConMed Corporation |
| Jul 6, 2026 | Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic | Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 15, 2026 | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. | Devices could potentially be occluded or partially occluded. | Class II | Intersurgical Inc |
| Jun 15, 2026 | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway... | Devices could potentially be occluded or partially occluded. | Class II | Intersurgical Inc |
| Jun 8, 2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atelli... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 14, 2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. ... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optic... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optic... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Le... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Opti... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... | Potential for overpressure alerts. | Class II | ConMed Corporation |
| May 14, 2026 | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. C... | Potential for overpressure alerts. | Class II | ConMed 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. |
| 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. |
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.