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 |
|---|---|---|---|---|
| Nov 3, 2021 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... | Class II | Haag-Streit USA Inc |
| Nov 3, 2021 | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the la... | Class II | Haag-Streit USA Inc |
| Apr 15, 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicros... | Examination data and patient name may be mixed up when printing or generating a pdf with the inte... | Class II | Haag-Streit USA Inc |
| Nov 20, 2020 | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref ... | Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered b... | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jan 5, 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... | There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... | Class II | Haag-Streit USA Inc |
| Aug 17, 2012 | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device... | The firm recalled the device after learning of a possible deviation in the stimulus luminance of ... | Class II | Haag-Streit USA 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.