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.

Clear
DateProductReasonClassFirm
Jul 25, 2013 ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro d... Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class II Siemens Healthcare Diagnostics, Inc
Jul 25, 2013 ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In v... Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Class II Siemens Healthcare Diagnostics, Inc
Jul 1, 2013 Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (D... Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimens... Class II Siemens Healthcare Diagnostics, Inc.
Jun 28, 2013 ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04... Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A... Class III Siemens Healthcare Diagnostics, Inc
Jun 25, 2013 ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN... ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for t... Class II Siemens Healthcare Diagnostics, Inc
Jun 19, 2013 Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Disp... Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems... Class II Siemens Healthcare Diagnostics, Inc.
Jun 5, 2013 Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass C... Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dis... Class II Siemens Healthcare Diagnostics, Inc.
May 20, 2013 Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - l... There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample dil... Class II Siemens Healthcare Diagnostics, Inc.
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 104936... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitr... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitative... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intende... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely conso... Under certain conditions the system may not perform as intended, causing the release of results t... Class II Siemens Healthcare Diagnostics, Inc.
May 10, 2013 ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 10, 2013 IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2... A rare variant of TSH, identified in a small cluster of patients, is not detected. Class II Siemens Healthcare Diagnostics, Inc
May 6, 2013 Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 ... Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sampl... Class II Siemens Healthcare Diagnostics, Inc.
May 2, 2013 Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417)... The product has the potential for false negative or delayed reaction for Arginine (ARG) results. ... Class II Siemens Healthcare Diagnostics, Inc.
Apr 25, 2013 Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an ... Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may r... Class II Siemens Healthcare Diagnostics, Inc.
Apr 22, 2013 HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for... Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... Class II Siemens Healthcare Diagnostics, Inc.
Apr 22, 2013 HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) fo... Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above A... Class II Siemens Healthcare Diagnostics, Inc.
Mar 13, 2013 ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 11, 2013 Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination o... Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the... Class II Siemens Healthcare Diagnostics, Inc.
Mar 6, 2013 Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... Class II Siemens Healthcare Diagnostics, Inc.
Feb 27, 2013 Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intend... Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... Class III Siemens Healthcare Diagnostics, Inc.
Feb 27, 2013 Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Inten... Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... Class III Siemens Healthcare Diagnostics, Inc.
Feb 27, 2013 Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). I... Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... Class III Siemens Healthcare Diagnostics, Inc.
Feb 22, 2013 Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) Th... Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(... Class II Siemens Healthcare Diagnostics, Inc.
Feb 21, 2013 Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used... Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(... Class II Siemens Healthcare Diagnostics, Inc.
Dec 20, 2012 Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The... Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable... Class III Siemens Healthcare Diagnostics, Inc.
Dec 20, 2012 Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in... The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no ... Class III Siemens Healthcare Diagnostics, Inc.
Dec 19, 2012 Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reage... Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/C... Class II Siemens Healthcare Diagnostics, Inc.
Dec 10, 2012 Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and... Class II Siemens Healthcare Diagnostics, Inc.
Dec 6, 2012 Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit... Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The c... Class III Siemens Healthcare Diagnostics, Inc.
Nov 27, 2012 Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR m... Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR F... Class II Siemens Healthcare Diagnostics, Inc.
Nov 14, 2012 Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 1... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test ... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The AD... Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 1049137... Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 090464... Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Nov 14, 2012 Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 ... Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room... Class II Siemens Healthcare Diagnostics, Inc
Oct 11, 2012 Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Desig... Firm has received reports from customers that the small pins at the bottom of the center door pan... Class II Siemens Healthcare Diagnostics, Inc.
Oct 10, 2012 Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP C... Correlation slope bias and accuracy shift 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.