State

Colorado product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3126–3150 of 79877

SevereFDA (Devices)·Z-1385-2026·2026-02-25
Medline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns
Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1371-2026·2026-02-25
Olympus Thunderbeat Surgical Device Recall Due to Adverse Events
Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.
Product
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1397-2026·2026-02-25
Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration
Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1387-2026·2026-02-25
Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues
Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1415-2026·2026-02-25
Medline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues
Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1365-2026·2026-02-25
Integra CVS Wound Dressing Recall Over Sterile Barrier Breach Risk
Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.
Product
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0511-2026·2026-02-25
IKM Aluminum Saucepan Recalled Over Lead Contamination Risk
Lotus Mom Corporation is recalling 56 units of the IKM Aluminum Saucepan 9" with Wooden Handle due to potential leachable lead contamination. The product was distributed in California and Colorado.
Product
IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MART
Category
Consumer Product
Distribution
2 states
SevereFDA (Devices)·Z-1354-2026·2026-02-25
Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk
Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.
Product
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1404-2026·2026-02-25
Medline Burn Care Kits Recalled Over Sterilization Calibration Issues
Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1352-2026·2026-02-25
Olympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI) because a software algorithm issue may cause overpressure events.
Product
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1414-2026·2026-02-25
Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration
Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1382-2026·2026-02-25
Olympus Thunderbeat Surgical Device Recall Over Adverse Events
Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.
Product
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Cardiac Surgical Convenience Kits Recalled Due to Sterility Calibration Issues
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2026·2026-02-25
Cochlear and head kits recalled over sterilization equipment calibration issues
Medline is recalling 9,051 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1373-2026·2026-02-25
Thunderbeat Type S devices removed after continued adverse event reports
Olympus is removing the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S from the market, stating the action is due to continued reports of adverse events.
Product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2026·2026-02-25
Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2026·2026-02-25
Arteriogram and catheter kits recalled over sterilization calibration issues
Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1395-2026·2026-02-25
Major laparotomy kits recalled over sterilization equipment calibration issues
Medline is recalling 82,597 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2026·2026-02-25
Olympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip devices due to reports of adverse events.
Product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2026·2026-02-25
Spinal and hip kits recalled over sterilization equipment calibration issues
Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2026·2026-02-25
Bronchoscopy robots recalled over arms that may move toward patient-left
Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.
Product
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2026·2026-02-25
Cervical disc implants recalled after 5mm product was labeled 6mm
Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.
Product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2026·2026-02-25
Medline C-Section Surgical Kits Recalled Over Sterilization Calibration
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
Product
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2026·2026-02-25
Endoscopy and angiography kits recalled over sterilization calibration issues
Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2026·2026-02-25
Triple lumen insertion kits recalled over sterilization calibration issues
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide