The Recall Desk

State

Colorado product recalls

20,304 recalls have nationwide distribution and so reach Colorado. 0 additional recalls listed Colorado specifically in their distribution scope.

About recalls in Colorado

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Colorado consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

10501–10525 of 20304

  • HighFDA (Devices)·Z-0844-2024·2024-02-07

    Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization

    Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.

    Product
    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2024·2024-02-07

    MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk

    Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.

    Product
    Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2024·2024-02-07

    EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

    Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

    Product
    EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2024·2024-02-07

    Knee replacement implant recalled for material oxidation risk

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.

    Product
    SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2024·2024-02-07

    Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates

    Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.

    Product
    MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2024·2024-02-07

    Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

    Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

    Product
    Achieva XR. Model (REF) Numbers 781153, 781253.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2024·2024-02-07

    Knee replacement inserts recalled due to material oxidation risk

    P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.

    Product
    P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2024·2024-02-07

    SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk

    Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2024·2024-02-07

    Knee replacement devices recalled due to potential material degradation

    Howmedica Osteonics Corp. recalls knee replacement devices with UHMWPE components manufactured from raw material over 5 years old due to potential oxidation that may affect material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2024·2024-02-07

    Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure

    American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2024·2024-02-07

    Cardiac central line insertion kits lack documented sterilization validation

    American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2024·2024-02-07

    Knee Replacement Component Recalled Due to Potential Material Degradation

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2024·2024-02-07

    Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail

    Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.

    Product
    Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2024·2024-02-07

    Custom Anesthesia Kits Recalled Over Sterilization Validation Failure

    American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.

    Product
    Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2024·2024-02-07

    Knee replacement component recalled due to potential material oxidation

    Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2024·2024-02-07

    Cardiac surgical kits recalled due to improper sterilization exposure

    American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.

    Product
    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2024·2024-02-07

    Tibial Knee Replacement Implants Recalled Due to Material Oxidation

    Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

    Product
    TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2024·2024-02-07

    Knee Replacement Device Recalled Due to Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0274-2024·2024-02-07

    Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications

    Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2024·2024-02-07

    Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure

    Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.

    Product
    EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2024·2024-02-07

    Knee Replacement Implant Components Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
    Category
    Medical Device
    Distribution
    Distributed nationwide