Browse Device Recalls
688 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 688 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 688 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry C... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | 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. |
| Oct 9, 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assa... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 8, 2012 | Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method ... | Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These sy... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPID... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoi... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These ... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 11, 2012 | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) ... | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 9, 2012 | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridg... | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibratio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 7, 2012 | ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 7, 2012 | ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is ... | Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jul 30, 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital... | Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 25, 2012 | Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ... | Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board th... | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 17, 2012 | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K408... | Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) r... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jul 17, 2012 | Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Hea... | Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dime... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 17, 2012 | Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Num... | Syphilis Assay Interference with HBsAg Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jun 7, 2012 | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informa... | There is a potential for the EasyLink system to display and transmit to the Laboratory Informatio... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classi... | The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation anal... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 29, 2012 | syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. ... | When using the syngo Quality Control package the system may not perform as intended for Multi-Rul... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 29, 2012 | EasyLink Informatic System is included with the Dimension Vista System. The ... | When using the EasyLink Quality Control Package the system may not perform as intended for Multi-... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 8, 2012 | Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B1... | Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antib... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 1, 2010 | BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usag... | Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithr... | 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.