Pennsylvania recalls

Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.

Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.

Medtronic Neurosurgery's Ventriculostomy Kit (REF: 46154) may contain endotoxin levels higher than safe limits for devices that contact cerebrospinal fluid during brain surgery. Endotoxin exposure can trigger acute inflammation in the brain and nervous system.

The 3mensio Workstation software may report heart and vessel measurements that are 0.8% to 34% larger than the actual size when specific conditions are met: the software is used with access only to 3D Echo or Mitral 3D Echo features, and the analysis involves Philips 3D echo datasets that contain Color Doppler data. This could lead to incorrect clinical measurements used in patient care decisions.

Certain Halyard EYE PACK convenience kits (Model LVEY27) contain Betadine solution at an incorrect concentration. The kits were distributed nationwide, primarily in California. No injuries have been reported.

SeaSpine Orthopedics has recalled certain Polyaxial Head spinal implants (REF 41-3010) due to a manufacturing error that may cause the polyaxial head to detach from the screw during surgery after insertion. This could require additional surgical intervention. The recall affects 796 units distributed worldwide, including nationwide US distribution and locations in Chile and Australia.

Olympus has identified a potential fault in the HDMI and DisplayPort connectors on certain OEV321UH 4K UHD LCD Monitors. This fault can result in image loss or display abnormalities. The recall affects 10 units with specific serial numbers distributed in Ohio, California, New Jersey, Florida, and Japan.

The roller assembly on the Ferno-Washington Power F2 Powered Fastening System may wear unevenly and deform, causing the rail mechanism to jam. If this happens, the stretcher cannot move along the rail—either with the powered system or manually—potentially delaying patient transport to a hospital.

ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.

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.

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.

Fusia Kimchi & Tofu Kimbap and Spicy Tuna with Gochujang Kimbap frozen meals contain fish that is not declared on the label. People with fish allergies who eat this product could have a serious allergic reaction.

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.