Browse Device Recalls
23 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 23 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 23 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Product testing did not meet expected stability criteria. | Class II | Cepheid |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 | Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 ce... | Class II | Cepheid |
| Aug 6, 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 0733294000... | As a result of Post-Market half-time stability testing, false negative test result was observed f... | Class II | Cepheid |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been inserted into the te... | Class II | Cepheid |
| Apr 24, 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| Apr 24, 2023 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... | Class II | Cepheid |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| Apr 9, 2019 | Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 7084535704... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Apr 9, 2019 | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226... | Product with incorrect shelf life. | Class II | Microbiologics Inc |
| Jan 31, 2019 | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 mo... | Class II | Microbiologics Inc |
| Oct 9, 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10... | Cepheid has received reports that some of our customers have experienced a higher number of temp... | Class II | Cepheid |
| Sep 15, 2017 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reve... | Customers have reported a higher than expected number of invalid test results when using the reca... | Class II | Cepheid |
| Jul 18, 2016 | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert... | Internal investigation found the certain lots of MRSA kits have the potential for performance iss... | Class II | Cepheid |
| Dec 1, 2015 | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets... | The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... | Class II | Microbiologics Inc |
| Dec 1, 2015 | QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets ... | The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... | Class II | Microbiologics Inc |
| Jul 27, 2015 | Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Mi... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... | Class III | Cepheid |
| Jul 27, 2015 | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/N... | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub com... | Class III | Cepheid |
| May 22, 2012 | BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in pa... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
| May 22, 2012 | BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part**... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
| May 22, 2012 | BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***G... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
| May 22, 2012 | BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***Gene... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
| May 22, 2012 | BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***Gen... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
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.