Browse Device Recalls
66 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 66 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 66 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 2, 2025 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Dec 2, 2025 | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni de... | Class II | Microbiologics Inc |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Class II | Microbiologics Inc |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics Inc |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the ta... | Class II | Microbiologics Inc |
| Jun 17, 2025 | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminu... | Class II | Microbiologics Inc |
| May 27, 2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product co... | Class II | Microbiologics Inc |
| Feb 20, 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... | The RSV target may give a late Ct value and could potentially not pass QC. | Class II | Microbiologics Inc |
| Feb 20, 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | Class II | Microbiologics Inc |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Jan 20, 2025 | Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv... | Internal quality control procedures were not followed correctly for the testing/release of three ... | Class II | Microbiologics Inc |
| Mar 6, 2024 | KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminate... | Class II | Microbiologics Inc |
| Jan 8, 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... | Class II | Microbiologics Inc |
| Oct 18, 2023 | LYFO-DISK, P. venetum, Catalog number 0794L | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... | Class II | Microbiologics Inc |
| Oct 18, 2023 | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... | Class II | Microbiologics Inc |
| Aug 14, 2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... | Class III | Microbiologics Inc |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Microbiologics Inc |
| Mar 24, 2022 | Inactivated macrolide and quinolone-resistant Mycoplasma genitalium | QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 22, 2022 | Inactivated macrolide-resistant Mycoplasma genitalium | The QC process was not adequate for the specification range. | Class II | Microbiologics Inc |
| Mar 3, 2022 | Pneumonia (33 Targets) Control Panel, unassayed quality control material, con... | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of... | Class II | Microbiologics Inc |
| Feb 25, 2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Distributed product did not undergo proper release testing. | Class II | Microbiologics Inc |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an ext... | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequ... | Class II | Microbiologics Inc |
| Aug 20, 2021 | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an e... | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically rele... | Class II | Microbiologics Inc |
| Feb 24, 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... | Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. | Class III | Microbiologics Inc |
| Feb 24, 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... | Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. | Class III | Microbiologics Inc |
| Dec 16, 2020 | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ... | Contamination with S. epidermidis | Class II | Microbiologics Inc |
| Dec 16, 2020 | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... | The expiration date on the label of one component (negative control 0243U) in the set lot is inco... | Class III | Microbiologics Inc |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, b... | Class II | Microbiologics Inc |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain t... | Class II | Microbiologics Inc |
| Oct 8, 2020 | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) | The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil... | Class III | Microbiologics Inc |
| Oct 8, 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... | KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain t... | Class II | Microbiologics Inc |
| Oct 8, 2020 | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage... | Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. | Class II | Microbiologics Inc |
| Oct 1, 2020 | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49... | Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. | Class II | Microbiologics Inc |
| Oct 1, 2020 | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co... | Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. | Class II | Microbiologics Inc |
| Oct 1, 2020 | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa... | Potential contamination with S. epidermidis E. coli and S. warneri. | Class II | Microbiologics Inc |
| Feb 18, 2020 | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... | Class II | Microbiologics Inc |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... | Class II | Microbiologics Inc |
| Feb 18, 2020 | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... | Class II | Microbiologics Inc |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verificatio... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... | Class II | Microbiologics Inc |
| Feb 18, 2020 | QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that ... | Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of sp... | Class II | Microbiologics Inc |
| Feb 12, 2020 | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Feb 12, 2020 | Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... | KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) ... | Class II | Microbiologics Inc |
| Jan 3, 2020 | Vaginal Verification Panel Ref 8208 Lot 8208-11 | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Poo... | Class II | Microbiologics Inc |
| Dec 16, 2019 | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel ... | The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivat... | Class II | Microbiologics Inc |
| 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 |
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.