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.

4676–4700 of 79881

HighFDA (Drugs)·D-0128-2026·2025-11-05
Testosterone 50 mg pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 4,829 sterile Testosterone Regular Release 50 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0338-2026·2025-11-05
Anti-siphon smallbore extension sets recalled over port weld separation risk
ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2026·2025-11-05
Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire
CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2026·2025-11-05
Purple cap administration sets recalled over port weld separation risk
ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Product
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0143-2026·2025-11-05
Sodium chloride injection bags recalled over potential flexible container leaks
Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0304-2026·2025-11-05
Vitrectomy probe accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling 577 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0363-2026·2025-11-05
ChemosafeLock bag spikes recalled over port weld separation risk
ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2026·2025-11-05
Infusion line packs recalled over incomplete seals in sterile pouches
Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2026·2025-11-05
Controlled substance safe towers recalled over fluid ingress causing smoke or fire
CareFusion is recalling 443 BD Pyxis CII Safe ES Tower Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2026·2025-11-05
Integrated drip chamber administration sets recalled over port weld separation risk
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Product
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
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 (Drugs)·D-0106-2026·2025-11-05
Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 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 (Drugs)·D-0135-2026·2025-11-05
Testosterone and triamcinolone 87.5 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 21,324 sterile Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2026·2025-11-05
13mm vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2026·2025-11-05
Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 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-0337-2026·2025-11-05
Oncology transfer kits recalled over port weld separation risk
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2026·2025-11-05
Surgical planning software recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Product
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2026·2025-11-05
Infusion pumps recalled over phantom touches on the touchscreen corner
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2026·2025-11-05
Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity
Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.
Product
PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2026·2025-11-05
Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 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-0308-2026·2025-11-05
Entry system accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2026·2025-11-05
Pyxis Medbank units recalled over fluid ingress causing smoke or fire
CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
Product
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0125-2026·2025-11-05
Testosterone 62.5 mg pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0133-2026·2025-11-05
Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
Category
Drug
Distribution
Distributed nationwide
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