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 |
|---|---|---|---|---|
| Jan 30, 2023 | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test fo... | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Contr... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 30, 2023 | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For ... | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead ... | Class II | Carestream Health, Inc. |
| Jan 27, 2023 | Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative dete... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH Total Protein II- In vitro diagnostic use in the quantitative det... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative de... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2023 | Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quant... | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig)... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 26, 2023 | Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (e... | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... | Class II | CooperVision, Inc. |
| Jan 26, 2023 | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... | Class II | CooperVision, Inc. |
| Dec 27, 2022 | MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Con... | Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor vis... | Class II | CooperVision, Inc. |
| Dec 7, 2022 | IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 7, 2022 | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMUL... | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 5, 2022 | Turbett Surgical Container, TS1200: Indicated for enclosing other medical dev... | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... | Class II | Turbett Surgical, Inc. |
| Dec 5, 2022 | Turbett Surgical Container, TS1000: Indicated for enclosing other medical dev... | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instr... | Class II | Turbett Surgical, Inc. |
| Nov 18, 2022 | Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction C... | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected d... | Class II | ConMed Corporation |
| Nov 17, 2022 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quanti... | Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPT... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 21, 2022 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Sep 20, 2022 | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone ... | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the ... | Class II | Angiodynamics, Inc. |
| Sep 19, 2022 | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro di... | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 19, 2022 | Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnost... | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 29, 2022 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-... | Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly ma... | Class II | Intersurgical Inc |
| Aug 10, 2022 | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55... | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimens... | Class II | Angiodynamics, Inc. |
| Jul 19, 2022 | VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jul 19, 2022 | VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... | Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 28, 2022 | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitativ... | Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Ir... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... | Class III | Zeiss, Carl Inc |
| Jun 23, 2022 | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... | A race condition between the storage system and services database has the potential to revert edi... | Class II | DICOM Grid, Inc. d/b/a Ambra Health |
| May 26, 2022 | Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ E... | On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in th... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 14, 2022 | Turbett Surgical Container, TS1500 | Devices were subject to unapproved rework processes. | Class II | Turbett Surgical, Inc. |
| Apr 13, 2022 | Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perfo... | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 13, 2022 | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perfo... | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 1, 2022 | Turbett Surgical Container, TS1500 | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barr... | Class II | TURBETT SURGICAL, LLC |
| Mar 16, 2022 | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device... | Users received sample collection kits that were assigned to another user. Incorrect shipping lab... | Class II | LetsGetChecked Inc. |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R... | Class II | Graphic Controls Acquisition Corporation |
| Feb 22, 2022 | Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Single Shot Epidural Tray Catalog 1165 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Epidural Tray Catalog 1577 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | MBB Tray Catalog Number: 9882 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalo... | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | 3.2MM Pellet Insertion Tray Catalog Number: B7345R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | CVC Dressing Change Kit Catalog Number: 2491R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Epidural Tray Catalog 1307 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Cervical Tray Catalog Number: 3765R2 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Single Shot Epidural Tray - 18G Catalog Number: 8139R2 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, 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.