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 |
|---|---|---|---|---|
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenz... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseri... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Jun 6, 2017 | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Ve... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Mar 2, 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Mar 2, 2017 | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| 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 17, 2015 | LYFO Disk | LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat... | Class III | Microbiologics Inc |
| Oct 6, 2014 | LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Ente... | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... | Class II | Microbiologics Inc |
| Oct 6, 2014 | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... | Class II | Microbiologics Inc |
| Oct 6, 2014 | KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (sin... | This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... | Class II | Microbiologics Inc |
| Mar 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Feb 11, 2013 | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My... | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL... | Class II | Microbiologics Inc |
| May 29, 2012 | Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr... | Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg... | 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.