Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product that include both f... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... | There is a potential for leaking vials for certain lot numbers where, if proper attire is not use... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r... | Class III | PerkinElmer Life and Analytical Sciences, Walla... |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 5, 2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 5, 2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
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.