The Recall Desk

State

Colorado product recalls

73,372 recalls have nationwide distribution and so reach Colorado. 6,945 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,945
Critical
1,218
Severe
1,823
Most recent
2026-10-02

Of the 6,945 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 1,823 (26%) are Severe.

Which agencies issued them

These figures cover only the 6,945 recalls whose distribution notice names Colorado specifically. The 73,372 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

17976–18000 of 80317

  • HighFDA (Devices)·Z-1324-2023·2023-04-12

    Medtronic Grafton Crunch sterile pouch packaging non-conformance recall

    Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.

    Product
    Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2023·2023-04-12

    Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects

    Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.

    Product
    Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0501-2023·2023-04-12

    Rosuvastatin 10mg tablets recalled for manufacturing process deviations

    RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2023·2023-04-12

    Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall

    Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.

    Product
    Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0492-2023·2023-04-12

    Doxazosin 2 mg tablets recalled for manufacturing practice deviations

    RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.

    Product
    Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0507-2023·2023-04-12

    Alprazolam 0.5 mg tablets recalled due to manufacturing contamination

    Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.

    Product
    Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2023·2023-04-12

    Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects

    Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.

    Product
    Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0504-2023·2023-04-12

    Alprazolam 0.25mg tablets recalled for potential cross contamination

    Preferred Pharmaceuticals is recalling Alprazolam 0.25mg tablets (Lot G1822K, expiration 5/31/2023) nationwide due to potential cross contamination from manufacturing deviations. No illnesses have been reported.

    Product
    Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2023·2023-04-12

    Rosuvastatin Tablets Recalled Due to Manufacturing Deviations

    Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2023·2023-04-12

    Medtronic Grafton Flex bone graft products recalled for packaging integrity defects

    Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.

    Product
    Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2023·2023-04-12

    CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding

    Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.

    Product
    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2023·2023-04-12

    Stryker Tourniquet Cuff May Fail to Hold Pressure During Surgery

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2023·2023-04-12

    Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.

    Product
    Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss

    Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2023·2023-04-12

    Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications

    Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.

    Product
    Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2023·2023-04-12

    Simvastatin Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.

    Product
    Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2023·2023-04-12

    Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations

    RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.

    Product
    Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2023·2023-04-12

    Glimepiride Tablets Recall Due to Manufacturing Quality Deviations

    Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.

    Product
    Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2023·2023-04-12

    Prescription Tadalafil tablets recalled for manufacturing process deviations

    Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2023·2023-04-12

    Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations

    RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.

    Product
    Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2023·2023-04-12

    Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations

    RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2023·2023-04-12

    Glimepiride Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2023·2023-04-12

    Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2023·2023-04-12

    Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.

    Product
    Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2023·2023-04-12

    Atorvastatin Calcium Tablets 20 mg Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.

    Product
    Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
    Category
    Drug
    Distribution
    Distributed nationwide