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.

51–75 of 75

  • ModerateFDA (Devices)·Z-1400-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media because the product may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit, K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit, K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.

    Product
    Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1401-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recall for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media due to potential performance failures after 106 days. The expiration date is shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1378-2019·2019-05-29

    Remel Inc Recalls Thio Med w/Dex, Hemin, Vit K Media

    Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.

    Product
    Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1402-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media due to potential failure to meet performance standards after 106 days from manufacturing.

    Product
    Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1405-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.

    Product
    Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3018-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies.

    Product
    remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3017-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies with anaerobic microorganisms.

    Product
    remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3019-2018·2018-09-19

    Remel Thioglycollate Medium Recalled for Performance Testing Failures

    Remel Inc is recalling Remel Thioglycollate Medium (Ref 05152) because products intermittently failed performance testing during stability studies.

    Product
    remel THIOGLYCOLLATE MEDIUM, REF 05152
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2137-2018·2018-06-20

    Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure

    Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.

    Product
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0895-2018·2018-03-14

    Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues

    Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2017·2017-02-01

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance

    Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.

    Product
    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provide
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0612-2017·2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2016·2016-05-04

    Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure

    Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.

    Product
    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0754-2016·2016-02-10

    Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.

    Product
    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2015·2014-12-03

    Remel TB Potassium Permanganate Stain Recalled for Performance Issues

    Remel Inc is recalling TB Potassium Permanganate stain due to potential cloudiness or discoloration that may affect mycobacterial diagnosis.

    Product
    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1792-2014·2014-06-25

    Roche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues

    Roche Diagnostics is recalling cobas 8000 analyzer filters that may cause discrepant results, alarms, or foam under certain conditions.

    Product
    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1785-2014·2014-06-25

    Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues

    Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.

    Product
    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0717-2014·2014-01-22

    Leica Biosystems Recalls BOND Polymer Refine Red Detection Due to Fungal Contamination

    Leica Biosystems is recalling BOND Polymer Refine Red Detection kits because they may contain fungal contaminants that can cause staining sensitivity loss or fluid delivery obstructions.

    Product
    Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric a
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-0569-2014·2014-01-01

    Siemens IMMULITE Folic Acid Kits Recalled for Potential Expiration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE Folic Acid kits due to a potential accelerated decline in counts that may cause failed adjustments before expiration.

    Product
    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1451-2013·2013-06-12

    Maytex Comfort Ear-Loop Face Masks Recalled for Performance Failures

    Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.

    Product
    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
    Category
    Medical Device
    Distribution
    Distributed nationwide