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 |
|---|---|---|---|---|
| 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. |
| Mar 18, 2024 | DURAMAX STACKED TIP 28CM 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 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. |
| Mar 18, 2024 | DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in a... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in ... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use ... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAFLOW 2, 55CM STRAIGHT BASIC KIT 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. |
| Mar 18, 2024 | DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-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 | DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H78710302... | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to ... | Class II | Angiodynamics, Inc. |
| Mar 18, 2024 | DURAMAX STACKED TIP 32CM 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, 32CM STRAIGHT BASIC KIT 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. |
| Mar 13, 2024 | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human ... | Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica C... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 1, 2024 | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... | Potential for positively biased results due to signal reduction over shelf life. | Class II | Ortho-Clinical Diagnostics, Inc. |
| Feb 27, 2024 | VITROS Performance Verifier II | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... | Class II | Ortho-Clinical Diagnostics |
| Feb 27, 2024 | VITROS Performance Verifier I | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifie... | Class II | Ortho-Clinical Diagnostics |
| Feb 7, 2024 | DCA Systems HbA1c Reagent Kit | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a po... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutan... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the pe... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the p... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percuta... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | Class II | Angiodynamics, Inc. |
| Jan 30, 2024 | MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percu... | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgic... | 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.