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Medline is recalling 11 groups of surgical convenience kits. The kits contain a component that the manufacturer recalled because it may be contaminated. No injuries have been reported, and the kits were distributed in 18 states.

Moderate·FDA·Sep 2, 202611 products

Some ConMed Linvatec GENESYS CrossFT Suture Anchors (REF# CFBC-5502B, Lot 1513167) may contain an incorrect patient implant card. This card is used to identify and track the device after implantation, so an incorrect card could lead to confusion about which device was used.

Moderate·FDA·Sep 2, 2026·ConMed

Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.

Moderate·FDA·Sep 2, 2026

Henry Schein is recalling two dental restorative products, Structur 2 SC Temporary Resin Cartridge Refill and Grandio Universal Nano-Hybrid Restorative Material Capsules, with 974 units affected. Specific lots were distributed in the U.S. and Barbados with incorrect packaging and Instructions for Use from the FDA-cleared device.

Moderate·FDA·Sep 2, 2026·Henry Schein2 products

Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.

Moderate·FDA·Sep 2, 2026

Midmark is recalling two digital electrocardiogram (ECG) products, including the IQecg Digital ECG and the Digital ECG HD+12 and HD+15, because a communication anomaly may cause incorrect heart waveforms and an inaccurate beats-per-minute reading. The recall covers software versions of the IQecg Plugin starting with v10 and before v10.1.0.18. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Midmark2 products

AVID Medical is recalling seven Halyard medical kit products because the labeling does not disclose that the StatLock component contains natural rubber latex. The kits were distributed nationwide, including in Mississippi and Texas. No injuries have been reported.

Moderate·FDA·Sep 2, 20267 products

Merge Healthcare's PACS and OrthoPACS medical imaging workstations contain a software issue that may cause measurements to be displayed inaccurately. Version 9.5 is affected. The issue was identified in 20 units distributed across California, Florida, Kentucky, Nebraska, and Washington.

Moderate·FDA·Sep 2, 2026·Merge Healthcare

American Contract Systems is recalling 4 convenience kit models that contain Medline Red Rubber Intermittent Catheters. Medline found that representative samples did not meet applicable performance specifications. The kits were distributed in Iowa and Ohio, and no injuries have been reported.

Moderate·FDA·Sep 2, 20264 products

Medline Industries distributed 45 tracheostomy tube kits (SKU DYKM2330) with incorrect component labeling. The discrepancy between the kit label and its contents could lead to confusion during use. No injuries have been reported.

Moderate·FDA·Sep 2, 2026

Hollister has identified a manufacturing defect in select lots of Onli Hydrophilic Urethral Intermittent Catheters that may cause a protrusion on the catheter tip. This defect could lead to genitourinary trauma or bleeding during use.

Moderate·FDA·Sep 2, 2026·Hollister

Medline is recalling specific lots of its medical convenience kits that contain Pilling Wecksorb Neurosponges and Neurosponge Strips. The neurosponges may have endotoxin levels above specification. The recall covers four product groups, about 6,950 kits in total, distributed in several US states. No injuries have been reported.

Moderate·FDA·Sep 2, 20264 products

Philips Incisive CT scanners running software versions V4.5 or V5.0 may fail to start a clinical scan during Bolus Tracking imaging procedures. This could delay or prevent necessary diagnostic scans from being acquired.

Moderate·FDA·Sep 2, 2026

ZMB Enterprises' Addall XR Shot 1 liquid dietary supplement contains three undeclared ingredients that are banned or restricted by the FDA: 1,4-DMAA, Phenylethylamine, and Phenibut. The product was sold online between July and December 2025.

Serious·FDA·Sep 2, 2026

B. Braun Medical has recalled Lactated Ringer's Injection USP in 1000 mL EXCEL containers due to the presence of particulate matter. The affected lot is J4H077 with an expiration date of November 30, 2026. About 23,688 bags were distributed nationwide.

Serious·FDA·Sep 2, 2026

Hikma Pharmaceuticals is recalling specific lots of Ramipril Capsules 10 mg because testing found higher-than-allowed levels of dicyclohexylurea, a process impurity. The affected lots are AC5470A and AC5470B, both expiring July 2027. No injuries have been reported.

Moderate·FDA·Sep 2, 2026·Hikma Pharmaceuticals

Fresenius Kabi USA discovered that Tyenne (tocilizumab-aazg) Injection vials may contain glass particles. The contamination was found during an internal investigation. The affected lot is 16UI07, which expires August 31, 2028.

Serious·FDA·Sep 2, 2026

Apotex Corp. is recalling one lot of Paxil CR (paroxetine) 37.5mg extended-release tablets because the medication failed to meet dissolution specifications during 24-month stability testing. This means the tablets may not release the drug into the body as intended. The affected lot (TY9494, expiration 05/31/2027) was distributed nationwide.

Moderate·FDA·Sep 2, 2026

Mallinckrodt has recalled specific lots of Acthar Gel (repository corticotropin injection) due to the presence of glass and stopper pieces in the vials. This contamination could pose a risk if the affected medication is used. The recall affects 12,367 vials with lot numbers 1564-107 and 1564-107H, both expiring January 31, 2027.

Moderate·FDA·Sep 2, 2026·Mallinckrodt

FDA inspection found that Zicam Cold Remedy Medicated Nasal Swabs failed microbiological testing, meaning they may contain harmful microbes. The affected products were manufactured under conditions that did not meet federal safety standards. Specific lot numbers with expiration dates through August 2028 are involved.

Moderate·FDA·Sep 2, 2026·Arm & Hammer

Lupin Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream USP 0.05% because the active ingredient is not uniformly distributed throughout the product. This means some parts of the cream may contain too much or too little medication, which could affect how well it works.

Moderate·FDA·Sep 2, 2026

Accord Healthcare is recalling specific lots of levothyroxine sodium tablets (25 mcg) because they contain less active ingredient than labeled. Patients taking these tablets may not receive the full dose needed to manage their thyroid condition. The affected lots were distributed nationwide.

Moderate·FDA·Sep 2, 2026·Accord Healthcare12 products

B. Braun Medical Inc. is recalling three lots of 0.9% Sodium Chloride Injection (saline solution) used in hospitals and healthcare settings. The recalled product contains particles of zinc oxide that should not be present. Intravenous fluids contaminated with particulate matter can cause serious complications including blood clots and organ damage. No injuries have been reported so far.

Serious·FDA·Aug 27, 2026

American Contract Systems is recalling 2 lines of medical procedure kits and trays, 4,949 kits in total, distributed in Minnesota, Missouri, and Iowa. The recall follows Medicom's recall of specific lots of Ritmed Neurological Sponges, which may have unexpectedly variable endotoxin levels. No injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

restor3d Inc. is recalling specific lots of the Veritas Standard Glenoid Baseplate used in reverse shoulder replacement surgery. A manufacturing error created incorrectly machined screw holes that may prevent peripheral screws from engaging properly during surgery. The defect affects only the standard baseplate; patient-specific baseplates are not affected.

Moderate·FDA·Aug 26, 2026

ConvaTec's Esteem Body Soft Convex Urostomy Pouches may leak from the cap during normal use. This affects multiple model numbers distributed nationwide across the U.S. No injuries have been reported to date.

Moderate·FDA·Aug 26, 2026·ConvaTec

Medtronic is recalling three MiniMed insulin pump models (640G, 670G, and 780G) that were loaned out and may have been cleaned with products that are incompatible with the pump. This could damage the case or keypad, let moisture in, and cause the pump to deliver too much or too little insulin. No injuries have been reported. The recall covers 280 affected pumps and was distributed in several European countries.

Moderate·FDA·Aug 26, 20263 products

BMC Medical Co., Ltd. is reporting retroactive rework that was conducted on Luna G3 APAP devices at the 3B/React Health warehouse in 2024. This retroactive reporting involves approximately 20,160 units with specific serial numbers.

Serious·FDA·Aug 26, 2026·BMC Medical

Boston Scientific's ENROUTE Transcarotid Neuroprotection System Plus (a catheter used in certain vascular procedures) may experience separation or partial separation of the arterial sheath tip during use. The FDA has classified this as a Class I recall, the most serious type. Approximately 49,229 units with specific lot numbers are affected and were distributed worldwide.

Serious·FDA·Aug 26, 2026

Siemens is recalling two quinidine assay kits, the Syva EMIT 2000 and the Beckman Coulter Emit 2000, because certain lots may give falsely high quinidine measurements. Quinidine is a heart and antimalarial drug, so inaccurate results could lead to inappropriate treatment. The recall covers 75 units total and was distributed in California and Italy.

Serious·FDA·Aug 26, 20262 products