State

Colorado product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4751–4775 of 79881

HighFDA (Devices)·Z-0334-2026·2025-11-05
Oncology kits with vented vial spike recalled over port weld failure
ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break and leak.
Product
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2026·2025-11-05
Bag spikes with Clave additive port recalled over port weld separation
ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0310-2026·2025-11-05
Trocar sealing caps recalled over silicone fragments detaching from sealing component
Aesculap is recalling 140 sealing caps for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0353-2026·2025-11-05
Bag spikes with additive port recalled over port weld separation risk
ICU Medical is recalling 6,450 6.5-inch bag spikes with ChemoLock additive port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0410-2026·2025-11-05
Intraoperative ultrasound systems recalled over soldering that can shut them down
Medistim is recalling 14 MiraQ ultrasound systems because insufficient soldering in the Printer Support Module may loosen wires and cause the system to shut down.
Product
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0351-2026·2025-11-05
21 inch extension sets recalled over port weld separation risk
ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2026·2025-11-05
Smallbore extension sets recalled because port weld may separate and leak
ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2026·2025-11-05
Trocar sealing units with reducer recalled over detaching silicone fragments
Aesculap is recalling 26 sealing units for 10/12mm trocars with reducer because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2026·2025-11-05
Desipramine 25 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Product
DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2026·2025-11-05
Graduated connectors recalled because port weld may separate and leak
ICU Medical is recalling 1,700 Graduated Connectors with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0317-2026·2025-11-05
Magseed Pro 12 cm markers recalled over potential cotton fiber contamination
Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.
Product
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2026·2025-11-05
Oncology kits with ChemoLock port recalled over port weld separation
ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0320-2026·2025-11-05
Surgical navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2026·2025-11-05
Clave bag spikes recalled because port weld may separate and leak
ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0328-2026·2025-11-05
Single unit bag spikes recalled over port weld separation risk
ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ChemoLock Bag Spike, 01 units REF: CL-10-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2026·2025-11-05
Capillary blood tubes recalled for causing false positive lead test results
ASP Global is recalling 4,272,858 SAFE-T-FILL capillary blood collection tubes because tubes made between July 2023 and February 2025 cause false positive results on LeadCare testing systems.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0111-2026·2025-11-05
Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Product
DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0357-2026·2025-11-05
ChemoLock ports with Spiros recalled over port weld separation risk
ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2026·2025-11-05
ChemoLock vial spikes recalled because port weld may separate and leak
ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0105-2026·2025-11-05
Prazosin capsules recalled over nitrosamine impurity above the acceptable intake limit
Teva Pharmaceuticals USA is recalling 291,512 bottles of Prazosin Hydrochloride Capsules 2 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.
Product
PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0325-2026·2025-11-05
BrainSTORM surgical planner recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Product
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0401-2026·2025-11-05
Mixed regular and super tampon packs recalled for lacking 510k clearance
Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.
Product
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0149-2026·2025-11-05
Lisdexamfetamine 60 mg capsules recalled after failing dissolution at twelve month stability
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 60 mg after an out-of-specification dissolution result at the 12-month stability station.
Product
LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0145-2026·2025-11-05
Lisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability
Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.
Product
LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0402-2026·2025-11-05
Initiation coated and nude regular tampons recalled for lacking 510k clearance
Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Nude Regular Tampons because the product lacks 510(k) clearance.
Product
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Category
Medical Device
Distribution
Distributed nationwide