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Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.

Moderate·FDA·Jul 29, 2026

Boston Scientific found that some air leak complaints were linked to damage to the sheath's hemostatic valve. The damage can happen when the dilator is inserted at the wrong angle during setup, and it may allow air into the device, creating a potential air embolism. This recall covers four FARADRIVE steerable sheath versions, with about 776,000 units affected. No injuries have been reported.

Moderate·FDA·Jul 29, 20264 products

Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.

Moderate·FDA·Jul 29, 2026

Boston Scientific is recalling three FARASTAR pulsed field ablation generator products because the instructions for use shipped with them did not include information about the FARAPOINT PFA catheter. A total of 30 units were affected, distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. No injuries have been reported.

Moderate·FDA·Jul 29, 20263 products

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

Serious·FDA·Jul 29, 20263 products

Wilcox Industries has released a software enhancement designed to increase the safety of its BOSS Xe aiming devices. The company is notifying all customers who purchased these products that the update should be installed.

Moderate·FDA·Jul 29, 2026·Wilcox Industries

TNVitamins 100% Organic Moringa Capsules (1,200 mg) and Moringa Powder (96 grams) have been found to be contaminated with Salmonella. The contamination affects specific lot numbers: Capsules (Lot #2800, expires 2/2028) and Powder (Lot #2782, expires 5/2028). No illnesses have been reported to date.

Serious·FDA·Jul 29, 2026

Modern Warrior Ready, a dietary supplement sold in 60-capsule bottles, contains unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. The FDA identified these ingredients through analysis. The product was distributed nationwide from April 2022 through December 8, 2025.

Serious·FDA·Jul 29, 2026

Fresenius Kabi is recalling five injectable medicine products because hair was found in some vials. The products are Xylocaine (two sizes), Naropin, lidocaine HCl injection and glycopyrrolate injection, all made by Fresenius Kabi in Lake Zurich, Illinois, and sold nationwide. No injuries have been reported.

Moderate·FDA·Jul 29, 20265 products

Rising Pharma's Cyproheptadine Hydrochloride Syrup (2 mg/5 mL, 473 mL bottles) is being recalled because the medication is crystallizing and forming particles that float in the bottle. This affects specific batches distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Rising Pharma

Rohto-Mentholatum is recalling eight Rohto Cooling Eye Drops products because they lack assurance of sterility, meaning the drops may not be guaranteed free of microbial contamination. All eight are sold under the Rohto Cooling Eye Drops name: ALL-IN-ONE, Max Strength (three versions), Optic Glow, Digi Eye, Dry Aid (single and twin pack), and Cool Relief. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Rohto-Mentholatum8 products

Asclemed USA Inc. is recalling Lidolog Kit, which contains lidocaine injection, because the label wrap covers the barcode, making it difficult to scan. This labeling defect affects 18 kits distributed in Tennessee.

FDA·Jul 29, 2026·Asclemed

Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10 mg/20 mg) because the olmesartan medoxomil active ingredient is below the required amount. This means affected tablets may not work as intended to lower blood pressure.

Moderate·FDA·Jul 29, 2026

Major Pharmaceuticals is recalling one lot of Levothyroxine Sodium Tablets, USP, 25 mcg due to subpotency — meaning the tablets contain less active ingredient than labeled. This affects Lot N02212 with an expiration date of 07/2026. Patients taking subpotent levothyroxine may not receive the full intended dose of this thyroid hormone replacement medication.

Moderate·FDA·Jul 29, 2026·Major Pharmaceuticals12 products

Precision Dose Inc. is recalling one lot of Glycopyrrolate Oral Solution (1 mg/5 mL) due to an unidentified impurity found during routine stability testing that does not meet specification. The affected lot (506033) expires November 30, 2026. This medication is prescription-only and supplied in unit-dose oral syringes.

Moderate·FDA·Jul 29, 2026·Precision Dose

Sunny Pharmtech is recalling three lots of Cyclophosphamide for Injection (1g and 2g vials) distributed between May 2024 and October 2024 because steel particles were found in the product. No injuries have been reported so far, but steel particles in an intravenous injection could cause serious complications including blood clots and infection.

Serious·FDA·Jul 24, 2026·Sunny Pharmtech

Baxter is recalling one lot of Cefazolin in Dextrose Injection (a frozen antibiotic infusion bag) because cardboard particles were found in the solution. The affected lot (LD175708, expiring February 14, 2027) was distributed between March and June 2025. No injuries have been reported so far.

Serious·FDA·Jul 24, 2026

American Regent identified glass and paraformaldehyde particles in one lot of Papaverine Hydrochloride Injection (Lot #25202), a prescription medication used to improve blood circulation and treat muscle spasms. The particles could cause local irritation, blood vessel blockage, and serious complications including stroke.

Serious·FDA·Jul 24, 2026

Tosoh Bioscience recalled certain lots of its ST AIA-Pack Testosterone test due to a quality control issue that can produce falsely high or falsely low testosterone measurements. Inaccurate results may lead to unnecessary follow-up testing or delayed diagnosis.

Moderate·FDA·Jul 22, 2026·Tosoh Bioscience

The Photera 400 ultraviolet phototherapy device uses a sensor to measure and control UV output for treating skin disorders. A calibration error caused the sensor to report incorrect UV levels, which means patients may have received different doses than intended.

Moderate·FDA·Jul 22, 2026·Daavlin3 products

Maquet (now Getinge) identified that 205 units of the Vasoview Hemopro 2 endoscopic vessel harvesting system from a single lot were exposed to an incorrect sterilization dose during gamma sterilization processing. This occurred at a STERIS facility in New Jersey in late March 2026. The affected devices may not be adequately sterilized.

Moderate·FDA·Jul 22, 2026

3B Medical is recalling Rio II nasal pillows interfaces due to a packaging and labeling discrepancy affecting product size identification and device identifiers. The affected units have incorrect or mismatched labeling on certain lots, which could lead to patients receiving the wrong size for their CPAP or PAP therapy device.

Moderate·FDA·Jul 22, 2026·3B Medical

Medtronic is recalling two cardiopulmonary bypass cannula products after receiving two complaints of loose foreign material, which was confirmed to contain trace amounts of blood. No injuries have been reported. The recall covers two products and was distributed nationwide in several US states as well as worldwide.

Moderate·FDA·Jul 22, 20262 products

Medline is recalling two total knee kits, with 163 units of each, because the Zimmer Biomet mixing bowls and spatulas packed inside were recalled for seal problems that could break sterility. Distribution was limited to California and Utah. No injuries have been reported, and the likely health effect is a short delay in surgery while another device is found.

Moderate·FDA·Jul 22, 20262 products

Papablic is recalling two models of replacement brush heads because the brush heads may break. No injuries have been reported. About 28,100 packs are included in the recall across both models, which were distributed nationwide.

Moderate·FDA·Jul 22, 2026·Papablic2 products

Orthofix is recalling four MiniRail external fixation devices, 161 units in total, because some units may carry the wrong model number. The M101 and M103 labels may be swapped, and some M122 units may be labeled M111. No injuries have been reported.

Moderate·FDA·Jul 22, 20264 products

GE HealthCare found that some Optima XR200, XR220, and XR240amx mobile X-ray systems that had a column replacement may not have had their safety pawl tested to confirm proper assembly. If the internal counterpoise cable fails, the column safety mechanism may not work, and the X-ray tube and collimator arm could drop down the column during an exam. The recall covers 66 units across three products. No injuries have been reported.

Moderate·FDA·Jul 22, 20263 products

Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.

Moderate·FDA·Jul 22, 2026

ICU Medical is recalling two infusion pump products, the Plum Duo and Plum Solo Precision IV Pump, because in a specific scenario the pump may not count down the Volume to be Infused on its Delivery screen and could deliver up to twice the programmed volume at the set rate. The recall covers about 17,584 units distributed across the US and Canada, and no injuries have been reported.

Serious·FDA·Jul 22, 20262 products

Arm drapes used with Intuitive Surgical's da Vinci SP robotic surgical system may detach from the instrument arm due to a defect in the drape rings at the top of the product. If a drape detaches during surgery, it can expose part of the instrument arm and may delay the procedure or require switching to an alternative surgical approach.

Moderate·FDA·Jul 22, 2026