The Recall Desk

Hazard

Treatment Delay recalls

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

What the numbers show

Total
90
Critical
0
Severe
14
Most recent
2026-05-06

Of the 90 treatment delay recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (16%) 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 treatment delay 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 90

  • SevereFDA (Devices)·Z-1947-2026·2026-05-06

    AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled

    North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.

    Product
    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, includ
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1922-2026·2026-04-29

    Beckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results

    Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.

    Product
    Access Total T4 Calibrator, Catalog No. 33805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2026·2026-04-22

    Cellex photopheresis kit centrifuge bowls may dislodge and break

    Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.

    Product
    Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2026·2026-04-08

    Jiffy composite polisher cups may crumble and break apart easily

    Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.

    Product
    Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1547-2026·2026-03-18

    TRUE METRIX AIR manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX AIR blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2026·2026-03-18

    TRUE METRIX PRO manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX PRO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1545-2026·2026-03-18

    TRUE METRIX manuals recalled as Class I over E-5 error code guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2026·2026-03-18

    TRUE METRIX GO manuals recalled as Class I over E-5 error guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2026·2026-03-18

    Beckman Coulter DxC 700 AU analyzer may stop analyzing after errors

    Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    DxC 700 AU, REF: B86444, B86446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2026·2026-03-18

    Beckman Coulter AU5800 analyzer may stop analyzing after database errors

    Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2026·2026-03-11

    Olympus lithotripsy reusable probes recalled over generator transducer recognition failure

    Olympus is recalling ShockPulse-SE Lithotripsy System reusable probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2026·2026-03-11

    Olympus lithotripsy generator recalled over transducer recognition failure

    Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2026·2026-03-11

    Olympus lithotripsy systems recalled over mis-wired component causing electrical noise

    Olympus is expanding a recall of ShockPulse-SE Lithotripsy Systems after finding additional generators with a mis-wired component that adds noise to the power supply output.

    Product
    Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1478-2026·2026-03-11

    Olympus lithotripsy single use probes recalled over generator recognition failure

    Olympus is recalling ShockPulse-SE Lithotripsy System single use probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2026·2026-02-04

    Chest drainage units recalled to limit their use to adults

    Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.

    Product
    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2025·2025-07-30

    Nellcor bedside SpO2 monitor alarms may not be heard or recognized

    The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.

    Product
    Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1969-2025·2025-06-18

    Azurion R1.x and R2.x X-ray systems software communication issue

    Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2025·2025-06-18

    Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall

    Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.

    Product
    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1919-2025·2025-06-18

    Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error

    Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay treatment or therapy.

    Product
    Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1917-2025·2025-06-18

    SCD Comfort Knee Length sleeves recalled for software logic errors

    Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.

    Product
    SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1916-2025·2025-06-18

    Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.

    Product
    LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2025·2025-03-26

    Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.

    Product
    BORN ON ARRIVAL KIT , Model No LLBN11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2025·2025-03-26

    Neuro IR Tray recalled over unconfirmed sterilization assurance

    American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.

    Product
    NEURO IR TRAY , Model No WENI56J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2025·2025-03-26

    General Angio Pack Sterilization Assurance Cannot Be Confirmed

    American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.

    Product
    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2025·2025-03-26

    Thoracic Packs Recalled for Unconfirmed Sterilization Assurance by Manufacturer

    American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.

    Product
    THORACIC PACK , Model No UTTC82Y UTTC82AA-01
    Category
    Medical Device
    Distribution
    Distributed nationwide