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.

7451–7475 of 79927

  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2025·2025-04-02

    Medline arthroscopy procedure kits recalled for defective plastic syringes

    Medline is recalling arthroscopy procedure kits containing plastic syringes with defects including leaks and breakage. The syringes may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

    Product
    Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2025·2025-04-02

    Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues

    Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2025·2025-04-02

    Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects

    Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.

    Product
    Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2025·2025-04-02

    Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure

    Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.

    Product
    Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2025·2025-04-02

    Baxter NovumIQ Syringe Infusion Pumps Recalled for Gasket Defect Risk

    Baxter Healthcare is recalling 149 NovumIQ syringe infusion pumps with incorrectly installed gaskets that could allow fluid ingress during cleaning or after IV fluid spills.

    Product
    Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0292-2025·2025-04-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination

    A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0295-2025·2025-04-02

    Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance

    QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2025·2025-04-02

    Contact lenses for astigmatism recalled due to incorrect cylinder power

    CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.

    Product
    Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUB
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1463-2025·2025-04-02

    Medline medical procedure kits recalled for plastic syringe defects

    Medline procedure kits with plastic syringes are being recalled due to potential leaks and breakage that may affect patient safety. The recall impacts 1152 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2025·2025-04-02

    Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect

    Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Quality Defects

    Medline procedure kits with defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall involves 422 units distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage

    Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0303-2025·2025-04-02

    Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue

    Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.

    Product
    SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2025·2025-04-02

    Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk

    Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2025·2025-04-02

    Medline Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2025·2025-04-02

    Progressa bed surfaces recalled for mattress dips when head elevated

    Baxter Healthcare's Progressa Bed Surfaces may develop dips in the mattress when the head of the bed is elevated, as air bladders inside can shift out of position. This could reduce the bed's effectiveness at preventing pressure ulcers.

    Product
    Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2025·2025-04-02

    Medline Procedure Kits With Defective Syringes Recalled Nationwide

    Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.

    Product
    Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk

    Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2025·2025-04-02

    Baxter TruSystem 7500 U Medical Device Software Malfunction Recall

    Baxter is recalling the Stationary column TruSystem 7500 U due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.

    Product
    Baxter Stationary column TruSystem 7500 U, Product Code 1730731
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2025·2025-04-02

    Baxter Mobile column TruSystem 7500 U emergency mode software issue affects back adjustment

    A software issue in the Baxter Mobile column TruSystem 7500 U prevents the upper back section from being operable or adjustable when emergency mode is enabled. Approximately 40 units distributed nationwide are affected.

    Product
    Baxter Mobile column TruSystem 7500 U, Product Code 1730720
    Category
    Medical Device
    Distribution
    Distributed nationwide