State

Colorado product recalls

73,381 recalls have nationwide distribution and so reach Colorado. 6,945 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total: 6,945
Critical: 1,218
Severe: 1,823
Most recent: 2026-10-02

Of the 6,945 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 1,823 (26%) are Severe.

Which agencies issued them

These figures cover only the 6,945 recalls whose distribution notice names Colorado specifically. The 73,381 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

19076–19100 of 80326

HighFDA (Drugs)·D-0122-2023·2023-01-18
BiMix Injection Recalled for Lack of Assurance of Sterility
Northern VA Compounders has recalled BiMix Injection due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider.
Product
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2023·2023-01-18
Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging
International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.
Product
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0125-2023·2023-01-18
Compounded Injectable Drug Recalled for Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 1,200 vials of BiMix STD 001 injectable nationwide due to lack of assurance of sterility. The compounded drug cannot be verified as sterile.
Product
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2023·2023-01-18
PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Product
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2023·2023-01-18
Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.
Product
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2023·2023-01-18
PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.
Product
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0112-2023·2023-01-18
Prostaglandin E1 Injection Vials Recalled for Sterility Issues
Northern VA Compounders PLLC is recalling Prostaglandin E1 Injection Solution vials nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider.
Product
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2023·2023-01-18
Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0930-2023·2023-01-18
Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk
Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.
Product
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0116-2023·2023-01-18
TriMix Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders is recalling TriMix Injection due to lack of sterility assurance. The compounded injectable medication may not meet required sterility standards.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2023·2023-01-18
Orthopedic Implant Cage Recalled for Incorrect Internal Material
Specific lots of CoreLink FLXFIT 15 orthopedic implant cages contain stainless steel internal components instead of the specified titanium alloy. The 18 affected units were distributed nationwide.
Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2023·2023-01-18
TriMix Plus 002 Injectable Medication Recalled for Sterility Concerns
FDA is recalling TriMix Plus 002, a compounded injectable medication, due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2023·2023-01-18
HCT 500mL Sterile Medical Bags Recalled for Potential Pinhole Leaks
Stradis Healthcare is recalling HCT 500mL sterile medical bags due to potential pinhole leaks near the seal that could compromise sterility. The recall affects 644 units distributed across nine U.S. states.
Product
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling QuadMix Standard 002 injectable medication because sterility of one lot cannot be assured. The recall affects 12 vials distributed nationwide.
Product
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0124-2023·2023-01-18
Compounded Injectable Medication Recalled Due to Sterility Assurance Concerns
Northern VA Compounders is recalling QuadMix Injectable due to lack of assurance of sterility. The FDA Class II recall affects compounded injectable medication distributed nationwide.
Product
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2023·2023-01-18
Compounded TriMix Injectable Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling 750 vials of TriMix Original injectable nationwide due to lack of assurance of sterility. Patients should discontinue use and consult their healthcare provider.
Product
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V011000·2023-01-18
Certain BMW R 1250 motorcycles recalled for gearbox input shaft defect
BMW is recalling certain 2019-2023 R1250GS, R1250GS Adventure, and R1250RT motorcycles because the gearbox input shaft may become damaged or break, possibly blocking the rear wheel and increasing crash risk.
Product
BMW — BMW R 1250 RT, R 1250 GS ADVENTURE, R 1250 GS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2023·2023-01-18
Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk
The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.
Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0117-2023·2023-01-18
Injectable Compounded Drug Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling 525 vials of TriMix Plus 001 injectable medication nationwide due to lack of assurance of sterility. Patients who received this product should consult their healthcare provider.
Product
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2023·2023-01-18
Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery
Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.
Product
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0119-2023·2023-01-18
Methylcobalamin Injection Recalled Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling Methylcobalamin Injection Solution (12.5mg/ml, 2 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0953-2023·2023-01-18
Medtronic RadiaLux Lighted Retractor recalled for defective sterile pouch seal
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
Product
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0255-2023·2023-01-18
Beijing Hawthorne Candy Recalled Due to Undeclared Sulfites
Northern Food I/E Inc. is recalling Beijing Hawthorne Candy due to undeclared sulfites. The product contains 7.32 mg sulfites per serving and has been distributed to 24 states.
Product
Beijing Hawthorne Candy
Category
Food
Distribution
24 states
HighFDA (Drugs)·D-0113-2023·2023-01-18
TriMix Injection Recall Due to Lack of Sterility Assurance
Northern VA Compounders PLLC is recalling TriMix Injection nationwide due to lack of assurance of sterility. The affected compounded injectable product comes in 2.5 mL vials with lot number 11142022@12.
Product
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0102-2023·2023-01-18
Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.
Product
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide