The Recall Desk

State

Colorado product recalls

72,986 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,941
Critical
1,218
Severe
1,507
Most recent
2026-09-09

Of the 6,941 recalls naming Colorado we have scored against our rubric, 1,218 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,507 (22%) are Severe.

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7001–7025 of 79927

  • SevereFDA (Devices)·Z-1637-2025·2025-05-07

    GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect

    GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.

    Product
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1632-2025·2025-05-07

    GE Healthcare CARESTATION 650C A1 Anesthesia System Ventilation Recall

    GE Healthcare CARESTATION 650C A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Ventilation can be achieved using alternate modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2025·2025-05-07

    epoc BGEM BUN Test Cards for Blood Analysis System Recalled

    Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V295000·2025-05-07

    2025 Freightliner trucks recalled for insufficient air tank capacity

    Daimler Trucks North America is recalling certain 2025 Freightliner, Western Star, and related models due to undersized air tanks that reduce braking performance and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 114SD, CASCADIA, BUSINESS CLASS M2, 49X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2025·2025-05-07

    Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles

    Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2025·2025-05-07

    Belmont Straight Inflow/Outflow Patient Line Kit recalled for potential connector crack

    Belmont Instrument LLC is recalling the Straight Inflow/Outflow Patient Line Kit (Model 902-00037) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leaks during use.

    Product
    Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2025·2025-05-07

    Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

    Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

    Product
    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V294000·2025-05-07

    2022–2024 Audi Q5 Engine Cylinder Head Cover Screws Fire Risk

    Volkswagen Group of America (Audi) is recalling certain 2022–2024 Q5 and Q5 Sportback Quattro vehicles due to cylinder head cover screws that may loosen, causing oil leaks and increasing fire risk. Dealers will inspect and replace the screws at no charge.

    Product
    AUDI — AUDI Q5 SPORTBACK, Q5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V293000·2025-05-07

    2025 Polestar 3 vehicles recalled for faulty rearview camera display

    Polestar is recalling certain 2025 Polestar 3 vehicles because the rearview camera image may not display when the vehicle is in reverse, reducing driver visibility and increasing crash risk.

    Product
    POLESTAR — POLESTAR POLESTAR 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2025·2025-05-07

    Belmont 3.0 Liter Disposable Set Recalled for Cracked Female Connector

    Belmont Instrument LLC is recalling the 3.0 Liter Disposable Set (Model 903-00032) due to a potential crack in the female connector on the Heat Exchanger/patient line set that can cause fluid leaks during device priming.

    Product
    3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2025·2025-05-07

    Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency

    Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Leaking at Seal Interface

    Medline is recalling sterile water and 0.9% normal saline bottles due to leaking at the peel-foil and bottle opening interface. The defect affects 159 units distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: HAND, REF DYNJ902002J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2025·2025-05-07

    Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer Recall

    Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0395-2025·2025-05-07

    Levothyroxine Sodium Tablets 50 mcg Recalled for Subpotency

    Accord Healthcare is recalling 4,872 bottles of Levothyroxine Sodium Tablets (50 mcg) nationwide because the tablets are subpotent and may not provide the intended therapeutic effect.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2025·2025-05-07

    Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations

    Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles distributed nationwide.

    Product
    Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2025·2025-05-07

    IceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings

    Boston Scientific is recalling 435 IceSeed 1.5 CX S cryoablation needles manufactured between April 2024 and February 2025 that were programmed with DEMO settings instead of Commercial settings, which can cause the Cryoablation System to prompt repeated tests if the needle is disconnected and reconnected.

    Product
    IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2025·2025-05-07

    Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles

    Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1713-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking

    Medline Industries is recalling Sterile Water and Sterile 0.9% Normal Saline bottles due to leaking at the peel-foil and bottle opening interface. The affected kits were distributed nationwide and internationally.

    Product
    Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2025·2025-05-07

    Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed

    Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.

    Product
    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1712-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals

    Medline procedure kits containing Sterile Water and Sterile 0.9% Normal Saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface.

    Product
    Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
    Category
    Medical Device
    Distribution
    Distributed nationwide