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 |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
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.