Colorado recalls

Sold nationwide. Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.

Moderate·FDA·Jul 1, 2026·Zimmer Biomet

Sold nationwide. Medtronic recalled three models of its Octopus tissue stabilizers, covering 1,012 units in total. During manufacturing, the company found that the tubing was attached backwards, with the short tube on the bottom of the canister and the long tube on top. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·Medtronic3 products

Sold nationwide. Certain lots of Dexcom G7 continuous glucose monitoring sensors that were designated for destruction were stolen and later sold to pharmacies and distributors without authorization. Two affected lots have different risks: one was not properly sterilized and poses an infection risk, and the other may not provide accurate readings or detect dangerous blood sugar levels.

Moderate·FDA·Jul 1, 2026·Dexcom

Sold nationwide. Surgify Medical is recalling 19 Surgify Halo drill burr products used in bi-portal endoscopic spinal surgery because the burrs may break during use. The recall was filed as a Class II device recall, and no injuries have been reported. The products were distributed nationwide, including to MN, MA, IN, LA, CA, NY, and FL.

Moderate·FDA·Jul 1, 2026·Surgify Medical19 products

Sold nationwide. A software issue in the Thuvera Laser Console (Software Version 2.2) causes the device to display a false error code 5018. This anomaly may lead clinicians to misinterpret the device status during operation.

Moderate·FDA·Jul 1, 2026·IPG Medical

Sold nationwide. GE Healthcare's AW Server 3.2 ext.6.5 has a software issue that can cause the system to display a previous patient's medical images instead of the correct patient's images when launching certain applications. There is no warning or error message when this happens. If a radiologist or clinician does not notice the error, they could misread images, make wrong diagnoses, or recommend incorrect treatment.

Moderate·FDA·Jul 1, 2026·GE

Sold nationwide. Stryker Neurovascular's INZONE Detachment System devices may experience premature battery drain, causing them to fail to power on, display faint indicators, or be unable to detach an embolization coil as intended. If a device fails during a procedure, medical staff may need to use an alternative technique to complete the intervention.

Moderate·FDA·Jul 1, 2026·Stryker

Sold nationwide. Acumed Hexalob Screws used in wrist fixation systems may break during use due to a manufacturing error. The affected screws come in various sizes (2.7mm and 3.0mm) and have been distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·Acumed

Sold nationwide. Zimmer Biomet is recalling five Off-Axis shoulder system reamer guide products distributed nationwide. The company received five complaints that the plastic guides caught during reaming and broke. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·Zimmer Biomet5 products

Sold nationwide. PFM Medical's Multi-Snare Set catheters (5 mm and 10 mm models) failed to meet biocompatibility safety standards. If used, the device material could cause localized inflammation and tissue irritation when in contact with blood vessels.

Moderate·FDA·Jul 1, 2026·PFM Medical

Sold nationwide. Ventec Life Systems' VOCSN+Pro respiratory ventilator may have a damaged backup battery that powers the alarm system. If primary power is lost and the backup battery is depleted or absent, the backup alarm may not sound to alert caregivers of the power loss.

Serious·FDA·Jul 1, 2026·Ventec Life Systems

Sold nationwide. TMJ Solutions Inc. has recalled one custom temporomandibular joint implant (model CHG020) that may contain incorrect patient-specific components. The mismatch caused a poor fit, resulting in a right-sided open bite for the affected patient.

Moderate·FDA·Jul 1, 2026·TMJ Solutions

Sold nationwide. Philips is recalling two Avalon fetal monitor models, the FM20 and FM30, because the speaker connector may have been assembled incorrectly. Device cables can be pulled out of the housing, which may cause intermittent or permanent loss of speaker output. The recall includes 454 affected units, and no injuries have been reported.

Moderate·FDA·Jul 1, 2026·Philips2 products

Sold nationwide. Certain Da Vinci surgical systems were distributed with a defective E-brake retainer pin. If the structural column fails, this pin can prevent the E-brake from engaging, potentially causing uncontrolled motion of the robotic arm. The pin may also loosen or back out, restricting arm movement or causing uncontrolled motion that could injure patient tissue.

Serious·FDA·Jul 1, 2026·Intuitive Surgical

Sold nationwide. Medline is recalling four groups of convenience kits, 7,738 units in total, because they include lidocaine and bupivacaine injections from supplier Arrow. Those injections were recalled after an FDA inspection of the supplier found quality issues. No injuries have been reported.

Serious·FDA·Jul 1, 2026·Medline4 products

Sold nationwide. Pearl Milling Company Original Pancake & Waffle Mix Complete is being recalled because it contains undeclared milk and soy, which are not listed on the label. The product was distributed only in Puerto Rico. No injuries have been reported.

Serious·FDA·Jul 1, 2026·Pearl Milling Company

Utz is recalling six bagged potato chip products under its Zapp's and Dirty brands, including Zapp's Bayou Blackened Ranch, Zapp's Big Cheezy, Dirty Maui Onion, Dirty Salt and Vinegar, and Dirty Sour Cream and Onion. The chips may contain Salmonella, a germ that can cause serious illness. No illnesses have been reported.

Serious·FDA·Jul 1, 2026·Zapp's6 products

Sold nationwide. Spring & Mulberry is recalling 11 flavors of its 2.1 oz date-sweetened chocolate bars, including Mint Leaf, Mixed Berry, Earl Grey, Pure Dark, Pecan Date, and Blood Orange, because they may be contaminated with Salmonella. The bars were sold nationwide, and no illnesses have been reported.

Serious·FDA·Jul 1, 2026·Spring & Mulberry11 products

Sold nationwide. Motor City Pizza Co. 5 Cheese Bread products may contain Salmonella, a bacteria that can cause serious illness. The affected products were distributed nationwide to major retailers including Costco, Walmart, Target, and Kroger.

Moderate·FDA·Jul 1, 2026·Motor City Pizza Co

Sold nationwide. Sun Pharmaceutical discovered that some bottles labeled as containing 6mg Perampanel tablets actually contained 10mg tablets instead. This mix-up affects one lot (AE01763) distributed nationwide. Patients taking the wrong strength could receive an incorrect dose of this seizure medication.

Moderate·FDA·Jul 1, 2026·Sun Pharmaceutical

Sold nationwide. Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic does not contain the full strength stated on the label. Five specific production lots distributed nationwide do not meet the required potency standard, which means the product may not work as intended for oral antiseptic purposes.

Moderate·FDA·Jul 1, 2026·Elevate Oral Care

Sold nationwide. Some bottles of Lacosamide 100mg tablets may contain Selexipag 1000 mcg tablets instead. This mix-up happened during manufacturing and could cause patients to take the wrong medication. The recall affects specific lots distributed nationwide.

Moderate·FDA·Jul 1, 2026·Annora Pharma

Sold nationwide. CareFusion is recalling four sizes of BD ChloraPrep Clear and BD ChloraPrep FREPP Clear skin antiseptic applicators because wrinkles in the paper lid may break the seal, so the products may not stay sterile. No injuries have been reported. The products were distributed nationwide in the U.S. and to other countries.

Moderate·FDA·Jul 1, 2026·CareFusion4 products

PReye LLC is recalling all lots of PReye Vitamin See Antioxidant Preservative Free Eye Drops due to lack of assurance of sterility. The recall affects approximately 50 to 60 bottles distributed in Colorado. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·PReye

Sold nationwide. ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·ANI Pharmaceuticals

Sold nationwide. Direct Rx's packaged Duloxetine D/R 30 mg capsules contain levels of N-nitroso-duloxetine, a potentially harmful impurity, above FDA's recommended limit. This is a manufacturing quality issue affecting specific lots distributed nationwide.

Moderate·FDA·Jul 1, 2026·Direct Rx

Sold nationwide. Amgen is recalling five bottle sizes of two prescription heart and thyroid-related drugs, Corlanor (ivabradine) and Sensipar (cinacalcet), because the tablets may contain a foreign substance. The products were distributed nationwide, and no injuries have been reported.

Moderate·FDA·Jul 1, 2026·Amgen5 products

Sold nationwide. Ajanta Pharma USA Inc. is recalling one lot of fenofibrate 200 mg capsules due to manufacturing quality deviations discovered during inspection. The affected lot (PA02216, expiring 12/2029) was distributed nationwide.

Moderate·FDA·Jul 1, 2026·Ajanta Pharma

Sold nationwide. MAJOR Pharmaceuticals is recalling Methylergonovine Maleate Tablets, USP, 0.2 mg due to subpotency — meaning the tablets contain less active ingredient than labeled. The affected lots were distributed nationwide. This is a prescription medication used to control bleeding after childbirth.

Moderate·FDA·Jul 1, 2026·The Harvard Drug

Sold nationwide. Revival Animal Health is recalling several canine and goat milk replacer products because they contain inconsistent levels of vitamin D—some too low, some too high. Dogs fed these products may develop serious health problems ranging from vomiting and weakness to bone deformities (rickets in puppies) or kidney damage (from excess vitamin D). Two cases of rickets have been reported so far.

Serious·FDA·Jun 25, 2026·Revival Animal Health