The Recall Desk

Hazard

Performance Failure recalls

75 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
75
Critical
0
Severe
0
Most recent
2026-09-02

Of the 75 performance failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all performance failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 75

  • ModerateFDA (Devices)·Z-3002-2026·2026-09-02

    American Contract System Convenience Kits Recalled for Performance Failures

    American Contract Systems Inc is recalling 30 units of Convenience Kits because Medline catheters failed performance specifications.

    Product
    American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3003-2026·2026-09-02

    American Contract System Convenience Kit Recalled for Performance Failures

    American Contract Systems Inc is recalling 12 Convenience Kits containing Medline catheters because samples failed performance specifications.

    Product
    American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3000-2026·2026-09-02

    American Contract System Convenience Kit Recalled for Performance Failures

    American Contract Systems Inc is recalling 30 units of Convenience Kits containing Medline catheters because samples failed performance specifications.

    Product
    American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3001-2026·2026-09-02

    American Contract Systems Recalls Convenience Kits with Non-Conforming Catheters

    American Contract Systems Inc is recalling 30 units of Convenience Kits because the included Medline catheters did not meet performance specifications.

    Product
    American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2927-2026·2026-08-19

    Remel Neisseria meningitidis Gp C In Vitro Diagnostics Recall

    Remel Europe Ltd. is recalling specific lots of Neisseria meningitidis Gp C in vitro diagnostics that fail to meet performance criteria.

    Product
    Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2023·2023-01-11

    ETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.

    Product
    ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2023·2023-01-11

    FDA Recalls PPM Lombard TSA Culture Medium Due to Storage Temperature Exceedance

    Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.

    Product
    PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2021·2020-12-16

    Randox Mg R1 Magnesium Test Kit Recalled for Linearity Performance Failure

    Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.

    Product
    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2021·2020-11-11

    3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk

    3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 1,572,000 units distributed worldwide.

    Product
    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2021·2020-11-11

    3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk

    3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 156,600 units distributed worldwide.

    Product
    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2021·2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2021·2020-10-28

    Sobel Westex Disposable Isolation Gowns Recalled for Performance Failures

    Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.

    Product
    SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3032-2020·2020-10-07

    Ameditech Recalls CLIA Waived Rapid Drug Tests for Performance Failures

    Ameditech Inc is recalling various CLIA Waived Rapid Drug Tests because immunoassay enzymes failed performance standards, preventing consistent detection of compounds.

    Product
    CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3042-2020·2020-10-07

    Ameditech Recalls ProScreen Drugs of Abuse Tests Due to Performance Failures

    Ameditech is recalling ProScreen Drugs of Abuse Tests because immunoassay enzymes failed performance standards, causing inconsistent detection of compounds.

    Product
    ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3038-2020·2020-10-07

    Ameditech MicroTox Immunoassay Enzymes Recalled for Performance Failures

    Ameditech Inc is recalling MicroTox immunoassay enzymes because they failed to consistently detect compounds at labeled levels.

    Product
    MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3043-2020·2020-10-07

    Ameditech Recalls QuickTox Drug Screen DipCards Due to Performance Failures

    Ameditech is recalling QuickTox Drug Screen DipCards because immunoassay enzymes failed performance tests, meaning the products may not consistently detect all compounds at labeled levels.

    Product
    QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2020·2020-10-07

    Ameditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures

    Ameditech Inc is recalling 537,120 units of First Check 4 Panel Drug Cups because they may fail to consistently detect all compounds at labeled levels.

    Product
    First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3037-2020·2020-10-07

    Ameditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance

    Ameditech Inc is recalling 23,000 MicroScreen immunoassay units because they failed to consistently detect compounds at labeled levels.

    Product
    MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3036-2020·2020-10-07

    Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures

    Ameditech is recalling ImmuTest Drugs of Abuse Cups because they failed to consistently detect all compounds at labeled levels.

    Product
    ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3046-2020·2020-10-07

    Ameditech Recalls First Check 1 Panel Drug Cup Due to Performance Failures

    Ameditech Inc is recalling First Check 1 Panel Drug Cup (THC) units because immunoassay enzymes failed performance tests, preventing consistent detection of compounds.

    Product
    First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3040-2020·2020-10-07

    Ameditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures

    Ameditech is recalling iCup Dx14 Drug Screen Cups because immunoassay enzymes failed performance tests, causing inconsistent detection of compounds.

    Product
    iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH,
    Category
    Medical Device
    Distribution
    Distributed nationwide