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.

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DateProductReasonClassFirm
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Dec 20, 2024 Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein ... Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. Class II Randox Laboratories, Limited
Jun 7, 2024 RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) us... Cystatin C Reagent marketed without a 510 (k) Class II Randox Laboratories Ltd.
Apr 5, 2024 Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative ... Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that... Class III Randox Laboratories Ltd.
Mar 5, 2024 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351... Class II Randox Laboratories Ltd.
Mar 1, 2024 Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators use... The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference mat... Class II Randox Laboratories Ltd.
Feb 14, 2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Randox Laboratories Ltd.
Jan 31, 2024 Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin A... Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to othe... Class II Randox Laboratories Ltd.
Jan 31, 2024 Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbu... Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to othe... Class II Randox Laboratories Ltd.
Nov 29, 2023 RX Series Copper (Cu) Assay Ref. Number CU2340 Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to deta... Class II Randox Laboratories Ltd.
Nov 20, 2023 Calibration Serum Level 3 CAL2351 CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series inst... Class II Randox Laboratories Ltd.
Nov 20, 2023 Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry... Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-ass... Class II Randox Laboratories Ltd.
Nov 13, 2023 Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level... There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum ... Class II Randox Laboratories Ltd.
Nov 6, 2023 SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assa... A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when ... Class III Randox Laboratories Ltd.
Oct 11, 2023 RANDOX Total Bilirubin. Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with To... Class II Randox Laboratories Ltd.
Sep 6, 2023 RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (... RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Sep 6, 2023 RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: R... RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Sep 6, 2023 RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (re... RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Sep 6, 2023 RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Sep 6, 2023 RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Aug 3, 2023 Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Che... Class II Randox Laboratories Ltd.
Jul 19, 2023 Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us... As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Lab... Class II Randox Laboratories Ltd.
Jun 21, 2023 Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which sh... Class II Randox Laboratories Ltd.
Jun 13, 2023 Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (... Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bi... Class II Randox Laboratories Ltd.
May 4, 2023 Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... Delay in reporting results due to Quality Controls running high outside of range. Target value an... Class III Randox Laboratories Ltd.
May 4, 2023 Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... Delay in reporting results due to Quality Controls running high outside of range. Target value a... Class III Randox Laboratories Ltd.
Feb 1, 2023 CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro deter... The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samp... Class II Randox Laboratories
Nov 22, 2022 Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in ... Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... Class II Randox Laboratories Ltd.
Nov 22, 2022 Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality cont... Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... Class II Randox Laboratories Ltd.
Nov 22, 2022 Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in... Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing de... Class II Randox Laboratories Ltd.
Nov 1, 2022 IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum... Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... Class II Randox Laboratories Ltd.
Nov 1, 2022 IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum ... Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... Class II Randox Laboratories Ltd.
Aug 1, 2022 The Randox Serology I Positive Control contains the following analytes in hum... ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckm... Class II Randox Laboratories Ltd.
Jun 22, 2022 Randox Cholesterol- For the quantitative in vitro determination of Cholester... Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali... Class II Randox Laboratories Ltd.
Jun 9, 2022 Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 9, 2022 Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Mar 25, 2022 CK MB Calibrator, Catalogue Number CK2393 Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... Class III Randox Laboratories Ltd.
Nov 1, 2021 RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol i... When calibrating using the standard provided in the kit, the change in absorbance is lower than e... Class II Randox Laboratories Ltd.
May 10, 2021 NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA ... Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect va... Class II Randox Laboratories Ltd.
Apr 28, 2021 Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R An issue was identified where the software froze during processing of commands, which resulted in... Class II Randox Laboratories Ltd.
Mar 29, 2021 Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catal... Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across ... Class II Randox Laboratories Ltd.
Nov 13, 2020 Randox Rx Series Mg - Product Usage: For the quantitative in vitro determinat... Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... Class II Randox Laboratories Ltd.
Nov 13, 2020 Randox Mg R1 - Product Usage: For the quantitative in vitro determination of ... Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is redu... Class II Randox Laboratories Ltd.
Aug 11, 2020 Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage... An update to the carryover avoidance technical bulletin to introduce additional steps for reagent... Class II Randox Laboratories Ltd.
Aug 11, 2020 Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: devic... An update to the carryover avoidance technical bulletin to introduce additional steps for reagent... Class II Randox Laboratories Ltd.
Jul 30, 2020 AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol... Class II RANDOX LABORATORIES, LTD.
Jul 30, 2020 AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in v... Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol... Class II RANDOX LABORATORIES, LTD.
Jul 10, 2020 Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked... Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jul 10, 2020 Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the qu... Class II RANDOX LABORATORIES, LTD.
Jun 26, 2020 Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase te... Randox have confirmed imprecision of quality control and patient samples when using specific Rand... 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.