State

Colorado product recalls

73,741 recalls have nationwide distribution and so reach Colorado. 6,951 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total: 6,951
Critical: 1,215
Severe: 1,826
Most recent: 2026-10-28

Of the 6,951 recalls naming Colorado we have scored against our rubric, 1,215 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,826 (26%) are Severe.

Which agencies issued them

These figures cover only the 6,951 recalls whose distribution notice names Colorado specifically. The 73,741 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5526–5550 of 80692

HighFDA (Drugs)·D-0134-2026·2025-11-05
Testosterone and triamcinolone pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 31,124 sterile Testosterone / Triamcinolone Acetonide 62.5MG/12.5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
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 (Drugs)·D-0113-2026·2025-11-05
Compounded pain injection syringes recalled over presence of particulate matter
QuVa Pharma is recalling 75,885 syringes of its R.E.C.K. periarticular injection over the presence of particulate matter.
Product
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2026·2025-11-05
Sample preparation systems recalled over incorrect dead volumes in instructions
Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.
Product
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0137-2026·2025-11-05
Testosterone and triamcinolone 200 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 264,664 sterile Testosterone / Triamcinolone Acetonide 200MG/40MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01
Category
Drug
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 (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-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 (Devices)·Z-0307-2026·2025-11-05
Chandelier illuminators recalled over incomplete seals in the sterile pouch
Alcon Research is recalling 330 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' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2026·2025-11-05
Six inch extension sets recalled because port weld may separate and leak
ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2026·2025-11-05
73 inch smallbore extension sets recalled over port weld separation risk
ICU Medical is recalling 200 73-inch smallbore 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 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
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-0366-2026·2025-11-05
Parathyroid hormone assay recalled over falsely depressed results at low range
Siemens Healthcare Diagnostics is recalling 3,318 units of the IMMULITE 2000 Intact PTH assay over the potential for falsely depressed patient results at the low end of the assay range.
Product
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
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 (Drugs)·D-0101-2026·2025-11-05
Unit dose prazosin 1 mg cartons recalled over nitrosamine impurity
Amerisource Health Services is recalling 1,970 unit dose cartons of Prazosin Hydrochloride Capsules 1 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-0132-2026·2025-11-05
Testosterone and triamcinolone 37.5 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 43,424 sterile Testosterone / Triamcinolone Acetonide 37.5MG/7.5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0323-2026·2025-11-05
Endoscopic navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2026·2025-11-05
Non-sterile bulk ChemoLock ports recalled over port weld separation risk
ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0130-2026·2025-11-05
Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate
FarmaKeio Outsourcing is recalling 18,124 sterile Testosterone / Triamcinolone Acetonide 12.5MG/2.5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0124-2026·2025-11-05
Testosterone 50 mg pellets recalled over potential presence of metal particulate
FarmaKeio Outsourcing is recalling 829 sterile Testosterone 50 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
Category
Drug
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…
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-0322-2026·2025-11-05
SyncAR navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
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