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 |
|---|---|---|---|---|
| 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. |
| Oct 21, 2024 | Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantita... | Potential for falsely depressed auto-diluted results for samples above the measuring interval of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 11, 2024 | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, show... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Sep 16, 2024 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ... | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variab... | Class II | ImaCor Inc. |
| Aug 29, 2024 | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction ... | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... | Class II | CooperVision, Inc. |
| Aug 29, 2024 | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the cor... | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... | Class II | CooperVision, Inc. |
| Aug 21, 2024 | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (5... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 21, 2024 | Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500... | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the q... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2024 | Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quanti... | Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeti... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 29, 2024 | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material ... | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 29, 2024 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Numb... | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 10, 2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contai... | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 3, 2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, Inc. |
| Jun 18, 2024 | SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.... | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however t... | Class II | Angiodynamics, Inc. |
| Jun 14, 2024 | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fa... | Class II | Medical Depot Inc. |
| Jun 14, 2024 | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... | The tiller separates from the base/front caster assembly. If the knee walker fails, a user may f... | Class II | Medical Depot Inc. |
| May 21, 2024 | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. ... | VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biase... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 21, 2024 | IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO... | A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO... | Class II | Angiodynamics, Inc. |
| May 14, 2024 | VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the V... | Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration da... | Class III | Ortho-Clinical Diagnostics, Inc. |
| May 9, 2024 | First Source iQ Flex M. Portable cart and platform that supports an X-ray sys... | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... | Class II | First Source Inc |
| May 9, 2024 | First Source Vision M. Portable cart and platform that supports an X-ray syst... | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall ... | Class II | First Source Inc |
| May 8, 2024 | VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 120... | Class III | Ortho-Clinical Diagnostics, Inc. |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantita... | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Fre... | Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Mar 18, 2024 | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in a... | XXX | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attain... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attai... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, 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.