Indiana recalls

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.

Boston Scientific identified that certain FARADRIVE Steerable Sheath devices may develop damage to the hemostatic valve if the dilator is not inserted correctly during preparation. Valve damage can allow air to enter the device, which may lead to air embolism—a serious condition where air bubbles reach the bloodstream and heart.

Boston Scientific identified that certain lots of the FARADRIVE Steerable Sheath (CLEAR) may have a hemostatic valve that can be damaged during device preparation if the dilator is not inserted correctly. Valve damage can allow air to enter, potentially causing an air embolism and patient harm.

Boston Scientific has identified that certain lots of the FARADRIVE steerable sheath may develop damage to the hemostatic valve during preparation if the dilator is not inserted correctly. This valve damage can allow air to enter the device, which may lead to air embolism (air in the bloodstream) and patient harm.

Boston Scientific identified that improper dilator insertion during device setup can damage the hemostatic valve in the FARADRIVE Steerable Sheath. Valve damage may allow air to enter the device, potentially causing air embolism and patient harm. The risk occurs in a subset of affected units when the dilator is not inserted straight through the center of the valve.

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.

Boston Scientific distributed 11 FARASTAR PFA Generator devices with Instructions For Use that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed one FARASTAR Pulsed Field Ablation Generator with instructions that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed 18 FARASTAR Ablation Generator units in Europe with incomplete Instructions For Use (IFU). The labeling did not include information about the FARAPOINT PFA catheter, which is used with the device. This discrepancy could affect proper device setup and use.

Medline Industries is recalling specific surgical convenience kits used in joint replacement procedures because they contain a pain-reliever medication (Bupivacaine Hydrochloride in Dextrose) with quality problems. The medication was manufactured by Huons Co, Ltd. and distributed through B. Braun Medical. The quality issues were identified by the supplier and no injuries have been reported.

Medline Industries is recalling specific C-section convenience kits (SKU DYNJ910835 and DYNJ910835A) that contain an anesthetic medication with quality problems. The anesthetic, Bupivacaine Hydrochloride in Dextrose Injection, was recalled by its manufacturer due to quality issues.

Medline Industries is recalling specific Anterior Hip surgical kits (SKU DYNJ909640G) that contain a B. Braun convenience kit with Bupivacaine Hydrochloride in Dextrose Injection. The anesthetic component was manufactured by Huons Co, Ltd., which issued a voluntary recall due to quality concerns with the injectable drug.

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.

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.

Green Jeeva LLC's organic moringa powder (product code GJ96, lot 25/08001) tested positive for Salmonella. The powder was distributed in bulk to ingredient processors and distributors. No injuries have been reported.

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.

Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.

Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.

Hair was found in Naropin (ropivacaine hydrochloride) injection vials used for local anesthesia. The affected product is the 0.5% concentration in 20 mL single-dose vials. Approximately 92,600 vials from Lot #6133436 (expiration 10/2028) were distributed nationwide.

Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.

Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.

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.

Rohto Cooling Eye Drops Cool Relief may not meet sterility standards required for eye medications. The affected product was manufactured in Vietnam and distributed nationwide. No injuries have been reported to date.

Rohto Cooling Eye Drops Dry Aid (twin pack) distributed nationwide may not meet sterility requirements. The affected lots were manufactured in Vietnam and distributed by The Mentholatum Company. No injuries have been reported.

Rohto Cooling Eye Drops Dry Aid may not meet sterility standards required for eye medications. The affected product was distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Digi Eye may not meet sterility standards required for eye products. The affected lots were distributed nationwide. No injuries have been reported.

Rohto Cooling Eye Drops Optic Glow may not meet sterility standards required for eye products. The manufacturer cannot confirm that certain batches were manufactured under proper sterile conditions. No injuries have been reported.

Rohto Cooling Eye Drops Max Strength (a nasal decongestant eye drop product) was distributed without assurance that all units met sterility standards. The product is used directly in the eye, where any contamination could pose a risk of infection. This recall affects specific lot numbers distributed nationwide.

Rohto Cooling Eye Drops Max Strength in certain lots may not be sterile. The manufacturer cannot assure that these drops meet sterility standards required for safe eye use. No injuries have been reported.

Rohto Cooling Eye Drops ALL-IN-ONE in specific lots does not meet sterility standards required for eye products. The issue was identified during manufacturing quality checks. Affected lots are distributed nationwide and are sold in pharmacies and retailers.