Browse Device Recalls
1,361 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,361 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 1,361 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| May 22, 2025 | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/C... | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent pa... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 21, 2025 | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub... | Class II | Numed Inc |
| Apr 14, 2025 | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, o... | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and ca... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 11, 2025 | iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Syste... | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. | Class I | Medical Depot Inc. |
| Mar 24, 2025 | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... | It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 11, 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN):... | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 28, 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16242 | The head of the phoropter head could come loose and potentially detach due to a default in the as... | Class II | Reichert, Inc. |
| Feb 28, 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | The head of the phoropter head could come loose and potentially detach due to a default in the as... | Class II | Reichert, Inc. |
| Feb 27, 2025 | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... | a limited number of lots were manufactured with an incorrect cylinder power. | Class II | CooperVision, Inc. |
| Feb 4, 2025 | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... | Product is mislabeled with the incorrect fill volume. | Class II | Angiodynamics, Inc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/... | The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalo... | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the S... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 19, 2024 | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Cat... | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if th... | Class II | Ortho-Clinical Diagnostics, INc. |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Nov 25, 2024 | AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-20... | Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due ... | Class II | Angiodynamics, Inc. |
| Nov 4, 2024 | Atellica CI Analyzer. Catalog Numbers: 10947347. | Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on th... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
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.