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.

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DateProductReasonClassFirm
Feb 22, 2022 Pump Refill Kit Catalog Number: 7347R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Procedural Accessory Kit Catalog Number: 9665R2 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Core Biopsy Tray Catalog Number: 8673R4 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Pain Tray Catalog Number: 9883 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 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 Number: 8417 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Nerve Block Tray Catalog Number: 8415 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 22, 2022 Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 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: B9743 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... Class II Busse Hospital Disposables, Inc.
Feb 17, 2022 LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, produc... Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients ... Class II Kaneka America Corp
Feb 11, 2022 RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayS... Incorrect source to skin or surface distance (SSD) calculation may result in dose error when usin... Class II RaySearch America Inc
Feb 9, 2022 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1... Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Dec 10, 2021 VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales ... The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or re... Class II Ortho-Clinical Diagnostics, Inc.
Dec 1, 2021 Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in t... ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. P... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2021 VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted w... Class II Ortho-Clinical Diagnostics, Inc.
Nov 18, 2021 Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automat... (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for O... Class II Siemens Healthcare Diagnostics, Inc.
Oct 15, 2021 VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 ... Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-... Class III Ortho-Clinical Diagnostics, Inc.
Oct 11, 2021 Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive... Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay Class II Clark Laboratories, Inc.
Sep 20, 2021 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent ... Class II Siemens Healthcare Diagnostics, Inc.
Sep 20, 2021 Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reag... Class II Siemens Healthcare Diagnostics, Inc.
Aug 16, 2021 AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclu... When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... Class II Biodex Medical Systems, Inc.
Aug 16, 2021 Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusiv... When deleting a previously entered custom isotope, the software deletes the isotope, but not the ... Class II Biodex Medical Systems, Inc.
Jul 20, 2021 Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
Jul 20, 2021 Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
Jul 20, 2021 Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent meas... If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dr... Class II Welch Allyn Inc
Jul 20, 2021 Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12... Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
Jul 20, 2021 Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... Class II Angiodynamics, Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens wi... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable C... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Con... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposabl... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens ... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Len... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact L... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 19, 2021 SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Le... Misaligned placement of an axis mark can cause the patient to experience blurred vision Class II CooperVision Inc.
May 18, 2021 The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 13, 2021 Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t... Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2021 Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Materia... Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated... Class II Siemens Healthcare Diagnostics, Inc.
May 3, 2021 VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemi... Ortho investigated and confirmed the potential for unexpected failed calibration, and condition c... 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.