Browse Device Recalls
700 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 700 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 700 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 4, 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Nu... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 14, 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 14, 2016 | BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 13, 2016 | Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 104... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Jan 13, 2016 | IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE... | The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. | Class II | Siemens Healthcare Diagnostics, Inc |
| Dec 29, 2015 | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit)... | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). | Class II | Siemens Healthcare Diagnostics, Inc |
| 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 11, 2015 | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 11, 2015 | Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | 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. |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 24, 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number... | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodiu... | Class II | Siemens Healthcare Diagnostics Inc |
| Jul 28, 2015 | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, ... | When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one p... | 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. |
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.