The Recall Desk

State

Colorado product recalls

73,738 recalls have nationwide distribution and so reach Colorado. 6,951 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,951
Critical
1,215
Severe
1,826
Most recent
2026-10-28

Of the 6,951 recalls naming Colorado we have scored against our rubric, 1,215 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,826 (26%) are Severe.

These figures cover only the 6,951 recalls whose distribution notice names Colorado specifically. The 73,738 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4101–4125 of 80689

  • HighFDA (Devices)·Z-1314-2026·2026-02-18

    Breast biopsy needles recalled over particulates that can enter tissue

    Hologic is recalling 681,870 Brevera Breast Biopsy System disposable 9 gauge needles because particulates in affected devices can be deposited into breast tissue during use.

    Product
    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2026·2026-02-18

    Testosterone 200mg single pellets recalled over potential metal particulate

    Asteria Health is recalling 194,336 pellets of Testosterone, 200 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2026·2026-02-18

    Azurion 5 M20 systems recalled over tables that may move unexpectedly

    Philips is recalling 922 units of the Azurion 5 M20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0334-2026·2026-02-18

    Ketamine injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 1,410 bags of Ketamine HCl injection over a lack of assurance of sterility.

    Product
    ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2026·2026-02-18

    Pediatric catheter securement kits recalled over open swabstick seals

    Medline is recalling 450 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2026·2026-02-18

    Testosterone 25mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 89,074 pellets of Testosterone, 25.0 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0336-2026·2026-02-18

    Vancomycin injection bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling 1,578 bags of Vancomycin HCl injection over a lack of assurance of sterility.

    Product
    vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0496-2026·2026-02-18

    Movie house popcorn recalled because it may contain foreign material

    Lee's Commissary is recalling 6,480 packages of Red Button Movie House Popcorn, 24 oz, because the product may contain foreign material.

    Product
    Brand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1333-2026·2026-02-18

    Blood culture kits recalled over open swabstick applicator seals

    Medline is recalling 4,300 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2026·2026-02-18

    Testosterone 100mg single pellets recalled over potential metal particulate

    Asteria Health is recalling 153,498 pellets of Testosterone, 100 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2026·2026-02-18

    Vascular access kits and trays recalled over open swabstick seals

    Medline is recalling 21,854 units of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2026·2026-02-18

    Compact suction units recalled over electromagnetic noise above aviation limits

    Laerdal Medical is recalling 1,202 Compact Suction Unit 4 RTCA units because those made in a limited period may emit electromagnetic noise beyond the acceptable RTCA limits.

    Product
    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2026·2026-02-18

    Display adapters recalled after the wrong configuration file was used

    Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.

    Product
    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2026·2026-02-18

    Navigation osteotomes recalled over incorrect array connection geometry

    Alphatec Spine is recalling 7 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2026·2026-02-18

    Cetrorelix injection kits recalled over missing or duplicated needles inside

    Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.

    Product
    CETRORELIX ACETATE — CETRORELIX ACETATE (CETRORELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2026·2026-02-18

    Spinal navigation instruments recalled over incorrect array connection geometry

    Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1357-2026·2026-02-18

    Small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2026·2026-02-18

    Dental impression posts recalled over caps in the wrong colour

    Straumann USA is recalling 561 WB Impression Post Closed Tray units because the impression caps provided in the package are magenta instead of brown.

    Product
    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1356-2026·2026-02-18

    Extra small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2026·2026-02-18

    Large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1360-2026·2026-02-18

    Extra large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2026·2026-02-18

    Newborn monitor caps recalled over an incorrect sizing guide on labeling

    SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide