Browse Device Recalls
101 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 101 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 101 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase ... | Randox have confirmed imprecision of quality control and patient samples when using specific Rand... | Class II | RANDOX LABORATORIES, LTD. |
| Jun 26, 2020 | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipa... | Randox have confirmed imprecision of quality control and patient samples when using specific Rand... | Class II | RANDOX LABORATORIES, LTD. |
| Feb 18, 2020 | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Us... | The control target and range value for Sodium using the ISE indirect method has been assigned inc... | Class II | Randox Laboratories Ltd. |
| Dec 19, 2019 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041... | Software version UI2550642107 for the RX Daytona + instrument released to correct the following i... | Class II | Randox Laboratories, Limited |
| Dec 13, 2019 | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml | A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Ch... | Class III | Randox Laboratories Ltd. |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5052. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an ob... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an obser... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an ob... | Class II | Randox Laboratories, Limited |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... | Class III | Randox Laboratories, Limited |
| Aug 9, 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Aug 9, 2019 | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Jul 25, 2019 | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Prod... | Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range wa... | Class III | Randox Laboratories Ltd. |
| Jul 12, 2019 | This is an in vitro diagnostic product intended for use as a calibration seru... | Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for AL... | Class III | Randox Laboratories Ltd. |
| Jun 24, 2019 | RX Imola, Model Nos. RX4900 | There was a report of a malfunction with the sensor which resulted in an increase of temperature ... | Class II | Randox Laboratories, Limited |
| Jun 24, 2019 | RX Daytona, Model Nos. RX4040 and RX4041 | There was a report of a malfunction with the sensor which resulted in an increase of temperature ... | Class II | Randox Laboratories, Limited |
| Jun 11, 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This pr... | The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate a... | Class II | Randox Laboratories, Limited |
| Jun 10, 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generat... | Class III | Randox Laboratories, Limited |
| Apr 3, 2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Pro... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| Apr 3, 2019 | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Produc... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| 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. |
| May 4, 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro deter... | Abnormal premature termination of the software could affect the use of the analyser when running ... | Class II | Randox Laboratories |
| 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. |
| Aug 11, 2017 | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 11, 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconst... | Class III | Randox Laboratories |
| Aug 8, 2017 | Liquid Cardiac Control CQ5053 | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot ... | Class II | Randox Laboratories, Limited |
| Jun 29, 2017 | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2017 | ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| 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. |
| Apr 27, 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control m... | According to Randox Laboratories an investigation indicates a labelling error for 2 of the test m... | Class III | Randox Laboratories |
| Sep 16, 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid c... | An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20%... | Class II | Randox Laboratories |
| 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.