Browse Device Recalls
28 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 28 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 28 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2021 | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite... | Due to calibration curves producing a higher activity than routinely expected and that there may ... | Class II | The Binding Site Group, Ltd. |
| May 20, 2021 | FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Fre... | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% comp... | Class II | The Binding Site Group, Ltd. |
| Nov 18, 2020 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | Due to customer complaints of positive bias impacting quality control. The high and low level co... | Class II | The Binding Site Group, Ltd. |
| Apr 9, 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051... | A software issue that may affect the analyzer's result accuracy. | Class II | The Binding Site Group, Ltd. |
| Nov 6, 2019 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, P... | It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparis... | Class II | The Binding Site Group, Ltd. |
| Oct 7, 2019 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to... | Class II | The Binding Site Group, Ltd. |
| Jul 29, 2019 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | There is a potential that users may experience difficulty validating the calibration of the kit. ... | Class II | The Binding Site Group, Ltd. |
| Apr 25, 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (0... | A reagent in C reactive protein kits is not performing to specification and samples with known co... | Class II | The Binding Site Group, Ltd. |
| Feb 19, 2019 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Prot... | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | Class II | The Binding Site Group, Ltd. |
| Nov 6, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | Firm is offering advice to customers experiencing challenges when validating the calibration curv... | Class II | The Binding Site Group, Ltd. |
| Aug 12, 2018 | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For i... | A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with ... | Class II | The Binding Site Group, Ltd. |
| Jul 25, 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists... | After running the calibration curve, the recovery of the IgM kit control results decrease demonst... | Class II | The Binding Site Group, Ltd. |
| Mar 9, 2018 | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... | Class II | The Binding Site Group, Ltd. |
| Jan 4, 2018 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended... | The low and high controls for the product are returning results above the assigned values. | Class II | The Binding Site Group, Ltd. |
| Aug 23, 2017 | Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034... | The high control for the kit is recovering low and may be out of range for assigned values. | Class II | The Binding Site Group, Ltd. |
| Dec 23, 2016 | Optilite IgG4 Kit Product Code: LK009.OPT.A | A change to the lower end of the measuring range and product insert did not reflect the change.Th... | Class III | The Binding Site Group, Ltd. |
| Oct 28, 2016 | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, L... | A change in the calibration curve causing an increase in false prozone flags. | Class II | The Binding Site Group, Ltd. |
| Jul 5, 2016 | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Pr... | Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 3... | Class II | The Binding Site Group, Ltd. |
| May 13, 2015 | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientif... | Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in t... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"600... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Produ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is inte... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 L... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Sep 11, 2014 | Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit ... | Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen... | Class II | The Binding Site Group, Ltd. |
| Nov 28, 2012 | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in th... | Calibration curve activity has increased over time in the kit lots listed. | Class II | The Binding Site Group, Ltd. |
| Oct 9, 2012 | Digital RID Plate Reader and Software Product Code: AD400 | If a control ring is marked after reading, the software will not flag results that are out of the... | Class II | The Binding Site Group, Ltd. |
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.