Browse Device Recalls

530 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 530 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 530 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 16, 2023	Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) ...	A force sensor in the occlusion detector may drift out of calibration leading to increased occlus...	Class II	Smiths Medical ASD Inc.
Aug 16, 2023	Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0...	A force sensor in the occlusion detector may drift out of calibration leading to increased occlus...	Class II	Smiths Medical ASD Inc.
Aug 16, 2023	Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6	A force sensor in the occlusion detector may drift out of calibration leading to increased occlus...	Class II	Smiths Medical ASD Inc.
Jul 19, 2023	Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us...	As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Lab...	Class II	Randox Laboratories Ltd.
Jul 12, 2023	NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Do...	LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi...	Class II	Landauer
Jun 7, 2023	BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are a...	Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS D...	Class II	PTW-FREIBURG
May 18, 2023	VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di...	May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).	Class III	Ortho-Clinical Diagnostics, Inc.
May 2, 2023	V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring Syste...	The sensors may experience an out-of-box failure because after recalibration, the sensors stayed ...	Class II	SenTec AG
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Apr 5, 2023	ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibra...	Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia C...	Class II	Siemens Healthcare Diagnostics, Inc.
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Apr 5, 2023	Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL	There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result...	Class II	Beckman Coulter Inc.
Mar 6, 2023	EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Pr...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 6, 2023	EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Produ...	EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a r...	Class II	Philips North America Llc
Mar 1, 2023	Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K),...	Medtronic was made aware of a supplier calibration issue during the contract sterilization proces...	Class II	Covidien, LP
Mar 1, 2023	Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT ...	Medtronic was made aware of a supplier calibration issue during the contract sterilization proces...	Class II	Covidien, LP
Mar 1, 2023	Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG...	Medtronic was made aware of a supplier calibration issue during the contract sterilization proces...	Class II	Covidien, LP
Mar 1, 2023	Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl...	Medtronic was made aware of a supplier calibration issue during the contract sterilization proces...	Class II	Covidien, LP
Jan 9, 2023	ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 9, 2023	Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat...	Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 9, 2022	Alinity m System. The Alinity m System is designed to automate the steps...	The firm identified the following three potential issues which may have impacted ADUs installed o...	Class II	Abbott Molecular, Inc.
Nov 11, 2022	Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction U...	The instrument was found to be installed without plunger assemblies in the clamp bar for an Ampli...	Class II	Abbott Molecular, Inc.
Oct 13, 2022	VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides F...	Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathem...	Class II	Ortho-Clinical Diagnostics, Inc.
Oct 12, 2022	Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use	Abbott has identified potential performance issues for the Alinity m System software version 1.6....	Class II	Abbott Molecular, Inc.
Aug 31, 2022	MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19	Software calibration error with product equip with a Dose Area Product (DAP) meter. This results...	Class II	Micro-X Ltd.
Jul 19, 2022	The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.	Incorrect optical calibration	Class II	Abbott Molecular, Inc.
Jun 22, 2022	Randox Cholesterol- For the quantitative in vitro determination of Cholester...	Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali...	Class II	Randox Laboratories Ltd.
Jun 9, 2022	Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF...	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an...	Class III	Randox Laboratories Ltd.
Jun 9, 2022	Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On...	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an...	Class III	Randox Laboratories Ltd.
Apr 26, 2022	4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst...	Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre...	Class II	Daavlin Distributing Company
Apr 26, 2022	1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst...	Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre...	Class II	Daavlin Distributing Company
Mar 25, 2022	VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 184...	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 25, 2022	VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 25, 2022	VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 8, 2022	ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl...	This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a cal...	Class II	Abbott Laboratories
Feb 9, 2022	VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.	Invalid calibrations (out of range high) while using the product.	Class II	bioMerieux, Inc.
Dec 22, 2021	SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code A...	Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the devi...	Class II	Covidien, LP
Nov 10, 2021	SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825	Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B...	Class II	Beckman Coulter Inc.
Oct 15, 2021	Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite...	Due to calibration curves producing a higher activity than routinely expected and that there may ...	Class II	The Binding Site Group, Ltd.
Oct 12, 2021	Artis icono floor with software VE20C-diagnostic imaging angiography system ...	Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U...	Class II	Siemens Medical Solutions USA, Inc
Oct 12, 2021	Artis icono biplane with software VE20C-diagnostic imaging angiography system...	Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U...	Class II	Siemens Medical Solutions USA, Inc
Oct 12, 2021	Artis pheno with software VE20C- diagnostic imaging angiography system Mode...	Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U...	Class II	Siemens Medical Solutions USA, Inc
Sep 29, 2021	ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ...	Twelve software-related issues affecting software version 9.41 and earlier were identified. The i...	Class II	Abbott Laboratories
Sep 29, 2021	ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/...	Twelve software-related issues affecting software version 9.41 and earlier were identified. The i...	Class II	Abbott Laboratories
Sep 17, 2021	BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL T...	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reag...	Class II	Bio-Rad Laboratories, Inc.
Jul 29, 2021	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P...	Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru...	Class III	Sentinel CH SpA

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.