The Recall Desk

State

Colorado product recalls

72,968 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.

Which agencies issued them

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5426–5450 of 79909

  • HighFDA (Devices)·Z-2561-2025·2025-09-24

    Reverse shoulder liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners under REF 320-38 and 320-42 are recalled because the articular surface position falls outside the dimensional specification in the labeling. 61,334 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2025·2025-09-24

    Heartstring III 4.3 mm seal systems recalled over loading and deployment failures

    Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.

    Product
    Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2575-2025·2025-09-24

    DxH 600 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 600 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2025·2025-09-24

    Shoulder humeral liners recalled over articular surface outside dimensional specification

    Exactech Equinoxe Reverse Shoulder humeral liners in 38 mm and 42 mm sizes are recalled because the articular surface position falls outside the dimensional specification in the labeling. 11,542 units are affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2025·2025-09-24

    Hematology analyzers recalled over erroneously high hemoglobin results in some samples

    UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0649-2025·2025-09-24

    Lentil soup packs recalled because Yellow No. 5 and 6 are undeclared

    Campsite Lentejas, 4.0 oz, lot 52060, is recalled because Yellow #5 and Yellow #6 are undeclared. 154 packages are affected.

    Product
    CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC (
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2589-2025·2025-09-24

    Bardex Foley catheter trays recalled over inserts describing the wrong material

    SureStep Foley Tray Systems, REF A303316A lot NGJX6399, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.

    Product
    SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2025·2025-09-24

    Foley catheter trays recalled because inserts describe the wrong catheter material

    SureStep Foley Tray Systems, REF A303414A lot NGJY3685, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating, risking infection or allergic reaction.

    Product
    SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0585-2025·2025-09-24

    Breaded butterfly shrimp recalled over possible cesium-137 contamination in cases

    Frozen AquaStar Breaded Butterfly Shrimp, clean-tail, in 3 lb packages is recalled because the product may be contaminated with Cesium-137. 126 cases are affected.

    Product
    Frozen AquaStar Breaded Shrimp, Butterfly, Clean-Tail, 16/20 count/lb. 3 lbs. package. Net wt. per case 36lbs. (12x3lbs. packages per case). UPC 731149601192. Packed For: AquaStar Seattle, WA. Farm Raised Product of Indonesia.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·H-0611-2025·2025-09-24

    Frozen raw half shell oysters recalled over potential norovirus contamination

    Bulk frozen raw half shell oysters, 15 lb, from harvest dates in January 2025 are recalled because the product is potentially contaminated with norovirus. 1,705 cases are affected.

    Product
    (Bulk) Oyster, Frozen, Raw Half Shell, 15lb(6.8kg) UPC: 10087703078342 Harvest Dates: Jan 03,2025, Jan 14,2025
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2558-2025·2025-09-24

    Deep brain stimulation implant manuals recalled after wire breaks in generators

    The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.

    Product
    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0648-2025·2025-09-24

    Chilaquiles meal packs recalled over undeclared Yellow No. 5 and 6

    Charge-Up Chilaquiles, 3.5 oz, lot 52061, is recalled because Yellow #5 and Yellow #6 are undeclared. 566 packages are affected.

    Product
    CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXT
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2563-2025·2025-09-24

    CD20 antibody reagent recalled over weak staining causing false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis is recalled because of the potential for weak staining, which may result in false negative CD20 identification. 4,145 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2025·2025-09-24

    CD20 reagent lots recalled over weak staining risking false negative identification

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2CN, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 65 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2025·2025-09-24

    DxH 800 hematology analyzers recalled over erroneously high hemoglobin results

    UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.

    Product
    UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2025·2025-09-24

    CD20 antibody lots recalled over weak staining risking false negative results

    FLEX Monoclonal Mouse Anti-Human CD20cy for Dako Omnis, catalog GA60461-2J, is recalled because of the potential for weak staining that may result in false negative CD20 identification. 67 units are affected.

    Product
    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0583-2025·2025-09-24

    Cocktail shrimp recalled over possible contamination with cesium-137

    AquaStar Cocktail Shrimp with cocktail sauce, 6 oz packages sold at Walmart, is recalled because the product may be contaminated with Cesium-137. 22,500 cases are affected.

    Product
    AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master cases distributed to distributors in frozen condition. AquaStar Cocktail Shrimp, 4oz
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·H-0584-2025·2025-09-24

    Kroger cooked shrimp pieces recalled over possible cesium-137 contamination

    Frozen Mercado Kroger Cooked Shrimp pieces, medium peeled tail-off, in 2 lb packages, are recalled because the product may be contaminated with Cesium-137. 18,000 bags are affected.

    Product
    Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb packages per case). UPC 011110626196.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0658-2025·2025-09-24

    Technetium mertiatide kits recalled after out-of-specification sulphate in a raw material

    Sun Pharmaceutical's Kit for the Preparation of Technetium Tc 99m Mertiatide, lot AD70995, is recalled after an out-of-specification result for sulphate in the sodium tartrate dihydrate used in production. 1,870 kits are affected.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE — KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE (BETIATIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2025·2025-09-24

    Chlorpromazine 50 mg blisterpacks recalled over micro-organism on packaging coil

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide