The Recall Desk

Hazard

Performance Defect recalls

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

What the numbers show

Total
82
Critical
0
Severe
0
Most recent
2026-05-06

Of the 82 performance defect 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 defect 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 82

  • ModerateFDA (Devices)·Z-0750-2016·2016-02-10

    bioMérieux Recalls BacT/ALERT FA Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT FA culture bottles because non-normal shipping conditions may have degraded the media, potentially affecting microbial detection performance.

    Product
    BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0473-2016·2015-12-30

    Becton Dickinson Recalls Vancomycin Screen Agar Due to Growth Issues

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because expired and in-date products may show breakthrough growth of vancomycin-susceptible Enterococcus faecalis near the end of shelf life.

    Product
    Vancomycin Screen Agar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0489-2016·2015-12-30

    Ameditech Drugs of Abuse Tests Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 3,603 kits of 6 Panel Cup Body and Lid w/Adult (AU) because they show reduced reactivity for two specific benzodiazepine compounds.

    Product
    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2015·2015-09-23

    Medivators Recalls Hemocor HPH700 Hemoconcentrators Due to Low Ultrafiltration Performance

    Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.

    Product
    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is e
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2735-2015·2015-09-16

    Medtronic Hemocor Hemoconcentrators Recalled for Low Ultrafiltration Performance

    Medtronic Perfusion Systems is recalling Hemocor Hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2736-2015·2015-09-16

    Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance

    Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2015·2015-08-26

    Trilliant Surgical Recalls Non-Sterile Cannulated Screw Countersinks

    Trilliant Surgical Ltd. is recalling 102 units of non-sterile cannulated screw countersinks because their cutting efficiency was out of specification.

    Product
    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2015·2015-07-29

    Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects

    Gardner Denver Thomas Inc is recalling 370 units of the MEDI-PUMP Aspirator, Model 1242, because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2151-2015·2015-07-29

    Gardner Denver Thomas Recalls Medi-Pump Aspirators Due to Performance Issues

    Gardner Denver Thomas is recalling 508 Medi-Pump aspirators because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2149-2015·2015-07-29

    Gardner Denver MEDI-PUMP Aspirator Recalled for Performance Defects

    Gardner Denver Thomas Inc. is recalling 160 MEDI-PUMP Aspirators because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0965-2015·2015-01-21

    Biocare Medical Recalls MUM-1 Antibody Lots Due to Staining Intensity Issues

    Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.

    Product
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein enco
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2015·2014-12-24

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Due to Performance Issues

    JAS Diagnostics Inc. is recalling 390 units of Glucose Hexokinase (Liquid) Reagent because the product does not perform according to specifications.

    Product
    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2542-2014·2014-09-03

    BD Vacutainer CPT Cell Preparation Tubes Recalled for Poor Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer CPT Cell Preparation Tubes due to poor separation that reduces the number of recovered mononuclear cells.

    Product
    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2555-2014·2014-09-03

    Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

    Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

    Product
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2014·2014-07-02

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Lots for Performance Issues

    JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do not perform according to specifications.

    Product
    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1534-2014·2014-05-07

    Teleflex Recalls CAPIO Absorbable Surgical Sutures for Strength Defects

    Teleflex Medical is recalling CAPIO absorbable surgical sutures because they did not meet minimum resorption strength requirements. The recall affects 7,380 units distributed in the US, Ireland, and Singapore.

    Product
    CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2014·2014-01-22

    Lab Vision Estrogen Receptor Antibody Recalled for Performance Issues

    Lab Vision Corporation is recalling Estrogen Receptor AB-11 antibody because in-house testing showed no staining on breast cancer tissues.

    Product
    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2242-2013·2013-09-25

    3M Recalls Scotchcast Cast Padding Due to Water Repellency Issues

    3M is voluntarily recalling specific lots of Scotchcast Wet or Dry Cast Padding because the material does not consistently repel water, which may prolong cast drying times.

    Product
    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1972-2013·2013-08-21

    Edwards Recalls EndoReturn Arterial Cannula Due to Component Error

    Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.

    Product
    Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2013·2013-08-07

    SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues

    SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.

    Product
    Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1825-2013·2013-08-07

    SteriTec Biological Indicator Test Packs Recalled for Readout Time Issues

    SteriTec is recalling specific lots of Getinge Assure Accufast BI Test Packs because the readout time does not match label claims.

    Product
    Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2013·2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.

    Product
    ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece
    Category
    Medical Device
    Distribution
    Distributed nationwide