Browse Device Recalls
571 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 571 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 571 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 19, 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num... | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 3, 2015 | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine sta... | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 7, 2015 | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical... | Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 30, 2015 | Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SM... | Erroneous low results on a small number of reagent wells. There is the potential for under-recove... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 24, 2015 | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 12... | Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bia... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 28, 2015 | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 1072303... | ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the r... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 26, 2015 | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a cl... | Software Issues. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 27, 2015 | ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Use... | Low red blood cell control recoveries and low results for red blood cell patient samples when usi... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 23, 2015 | Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product... | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 15, 2015 | Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CRE... | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depres... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 30, 2015 | ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the qu... | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 21, 2015 | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimensi... | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop process... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 19, 2015 | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500... | System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVI... | Class II | Siemens Healthcare Diagnostics, Inc |
| May 19, 2015 | CentraLink" Data Management System; software is a network solution provider a... | Siemens Healthcare Diagnostics has determined that the sample query function that includes Instr... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 11, 2015 | Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro di... | Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 6, 2015 | The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing ... | D50 and D51 Diagnostic error codes are not functional. | Class II | Siemens Healthcare Diagnostics, Inc |
| May 6, 2015 | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (... | IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to s... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 6, 2015 | The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing ... | D50 and D51 diagnostic error codes are not functional. | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 29, 2015 | EasyLink Data Management System; a clinical data management system that assis... | System Limitations and Software Issues related to the following features: Custom reference range... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 20, 2015 | Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is a... | Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 9, 2015 | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement... | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parame... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 2, 2015 | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Di... | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been inst... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 25, 2015 | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin wit... | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 23, 2015 | ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. | Siemens internal investigation confirmed that current contamination avoidance settings do not pre... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 24, 2015 | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on... | A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 11, 2015 | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Versio... | Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 27, 2015 | ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catal... | ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 27, 2015 | ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic C... | ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 27, 2015 | ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catal... | ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 19, 2015 | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the... | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 15, 2015 | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination o... | Complaints have been confirmed on failed proficiency testing due to serum samples recovering too ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Dec 16, 2014 | ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x... | Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 24, 2014 | Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage:... | Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 5, 2014 | Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligen... | Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 27, 2014 | Turbo Troponin I For in vitro diagnostic use for the quantitative measurem... | Class II | Siemens Healthcare Diagnostics, Inc. | |
| Oct 20, 2014 | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I... | A typographical error regarding the expiration date was identified in the control module instruct... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 17, 2014 | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 17, 2014 | Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2014 | ADVIA Centaur XP Immunoassay System (including refurbished) Professional u... | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 9, 2014 | ADVIA Centaur (including refurbished) Professional use in a laboratory for... | A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may oc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... | Class III | Siemens Healthcare Diagnostics, Inc |
| Sep 30, 2014 | Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C... | Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2014 | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335... | Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortis... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 24, 2014 | siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used o... | Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status Power Supply Ad... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status Connect System ... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 19, 2014 | External power supply adaptors that accompany Clinitek Status+ The Clinite... | The external power supply for the Clintek Status analyzer, which is provided separately, is damag... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 15, 2014 | ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. C... | Increased imprecision and positive bias is observed with patient samples and negative controls an... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 15, 2014 | Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagno... | Increased imprecision and positive bias is observed with patient samples and negative controls an... | Class II | Siemens Healthcare Diagnostics, Inc |
| Sep 12, 2014 | ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ... | Stability of the ADVIA Centaur Cleaning Solution is not assured | Class III | Siemens Healthcare 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.