Browse Device Recalls
73 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 73 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 73 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2019 | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabele... | The form received three complaints related to the user obtaining a result that fell below the tar... | Class II | Response Biomedical Corp. |
| Mar 11, 2019 | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 | Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liqui... | Class II | Randox Laboratories Ltd. |
| Feb 13, 2019 | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality ... | An error in the assignment of the control range pH in Blood Gas Control | Class II | Randox Laboratories Ltd. |
| Feb 7, 2019 | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usag... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: ... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Dec 4, 2018 | Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1... | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent ca... | Class II | Randox Laboratories Ltd. |
| Dec 4, 2018 | Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Ars... | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent ca... | Class II | Randox Laboratories Ltd. |
| Dec 3, 2018 | Fructosamine Control 1, FR2994 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Dec 3, 2018 | Fructosamine Calibrator, FR2993 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Dec 3, 2018 | Fructosamine Control 3, FR2996 This product is intended for in vitro use ... | The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 ... | Class II | Randox Laboratories Ltd. |
| Nov 19, 2018 | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic... | Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP)... | Class II | Randox Laboratories Ltd. |
| Oct 2, 2018 | Liquid Cardiac Control, CQ5051 | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o... | Class II | Randox Laboratories Ltd. |
| Oct 2, 2018 | Liquid Cardiac Control, CQ5052 | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o... | Class II | Randox Laboratories Ltd. |
| Oct 2, 2018 | Liquid Cardiac Control, CQ5053 | Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 o... | Class II | Randox Laboratories Ltd. |
| Jun 8, 2018 | Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This pro... | The device is not suitable for the control of the Troponin T assay due to unacceptable variation ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| Mar 2, 2018 | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI83... | Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instrume... | Class II | Randox Laboratories Ltd. |
| Jun 7, 2017 | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDO... | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. Th... | Class II | Randox Laboratories Ltd. |
| Sep 7, 2016 | IgE Calibrator Series | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now ... | Class II | Randox Laboratories Ltd. |
| Aug 2, 2016 | Randox Lipase (Colorimetric) Product Usage: A lipase test system is a dev... | According to the firm carry over was observed when the Lipase test is run directly before or afte... | Class II | Randox Laboratories 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.