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Medline's Open Heart Convenience Kit (DYNJ43008N) contains a coronary cannula with a potential sterile barrier breach. If a compromised pouch seal isn't caught before use, the non-sterile device could cause infection or serious complications including blood cell breakdown, blood clots, or organ damage.

Serious·FDA·Sep 23, 2026

Medline is recalling seven groups of convenience kits because certain lots of sterile applicators may contain fungus (Aspergillus penicillioides). Skin preparation products contaminated with this fungus can cause serious infections, including sepsis, and death. The kits were distributed nationwide, and the FDA has classified this as a Class I recall, its most serious category.

Serious·FDA·Sep 23, 20267 products

Halyard IV START KIT convenience kits (Lot 1658437) contain applicators contaminated with Aspergillus penicillioides, a fungus. The contamination was found in BD ChloraPrep Clear and FREPP Clear applicators included in the kits. This is a Class I recall affecting 288 units distributed in Nebraska.

Serious·FDA·Sep 23, 2026

BD Switzerland has recalled multiple models of Alaris Pump Infusion Sets due to discrepancies in performance data attributes. These discrepancies may cause the infusion pump to operate inappropriately. No injuries have been reported.

Serious·FDA·Sep 23, 2026

Bard is recalling 2 product lines of short-term straight dialysis catheters, with about 172,500 units affected. The recall is downstream of a related Class I recall, RES 98777, and the filing does not describe the specific hazard. No injuries have been reported.

Serious·FDA·Sep 23, 20262 products

Foods Alive organic moringa leaf powder in 8oz pouches may be contaminated with Salmonella. About 1,691 pouches were distributed nationwide and online. No illnesses have been reported so far.

Serious·FDA·Sep 23, 2026

Vitruvias Therapeutics is recalling Thyroid Tablets, USP 1/2 Grain (30 mg) because the tablets are superpotent—meaning they contain higher-than-intended levels of active ingredients. This lot was distributed nationwide. The affected lot number is 504950, expiring 09/30/2026.

Serious·FDA·Sep 23, 2026·Vitruvias Therapeutics

Windstone Medical Packaging's AMS Convenience Kit DSAEK Pack contains saline solution bags with blue connector pieces that may detach from the infusion port during normal use. This could allow contamination or improper fluid delivery during ophthalmic surgery.

Serious·FDA·Sep 16, 2026

Nipro is recalling four hemodialysis concentrate products because they may contain high levels of endotoxin, a substance from bacteria. The recall covers about 13,000 cases and 100 drums across the US, Guatemala, and Panama, with US distribution in FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA. No injuries have been reported.

Serious·FDA·Sep 16, 20264 products

Medical Action Industries is recalling two epidural kit products, 5,566 units in total. The kits contain saline ampules that are part of a separate recall, and the kits may not be sterile. No injuries have been reported.

Serious·FDA·Sep 16, 20262 products

The Bravo CF capsule delivery device is used during esophageal pH monitoring procedures to attach a small capsule to the esophagus. The capsule may fail to attach properly or detach from the delivery device during use. This can result in the capsule being inhaled, perforating the esophagus, blocking the airway, or causing bleeding.

Serious·FDA·Sep 16, 2026·Given Imaging

B. Braun Medical Inc. is recalling specific lots of 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide, inorganic material, cellulose fibers, and polystyrene. The contamination was identified during quality testing. This is a sterile injectable product distributed nationwide.

Serious·FDA·Sep 16, 2026

American Regent's epinephrine injection (1 mg/mL, 30 mL vials) may contain particulate matter—including nylon, glass, and other materials—and some vials are broken or leaking. This affects the sterility and safety of the medication. Three specific lot numbers distributed nationwide are involved.

Serious·FDA·Sep 16, 2026

Baxter Healthcare identified stainless steel particles in certain 2000 mL bags of Dextrose Injection, USP 70%. The contamination affected 606 bags (Lot #Y495066, expiration July 31, 2027) distributed nationwide. No injuries have been reported.

Serious·FDA·Sep 16, 2026

Centric Compounding has recalled six lots of Glutathione, Myer's Cocktail, and Tri-Immune Boost injectable vials due to elevated endotoxin contamination. The company has received nine reports of adverse reactions including fever, chills, chest pain, nausea, vomiting, headache, and malaise. Elevated endotoxins in injectable products can cause serious medical events including fever, low blood pressure, inflammatory reactions, anaphylactic shock, and death.

Serious·FDA·Sep 11, 2026·Centric Compounding

Optimal Balance Pharmacy's Glutathione 200 mg/mL injectable solution failed quality testing and was found to contain bacterial endotoxin levels above safe limits. This contamination poses a risk of serious infection or systemic reaction when injected. The affected lot (LG342009076) was distributed nationwide.

Serious·FDA·Sep 9, 2026·Optimal Balance Pharmacy

Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers because some bags contain fiberglass particles. The affected lots are Y495523 and Y495523A, expiring October 31, 2027. No injuries have been reported.

Serious·FDA·Sep 9, 2026

Food to Live Organic SuperGrass Powder in 6 oz, 12 oz, 1 lb, and 4 lb containers has been recalled due to Salmonella contamination. The affected products were distributed across the United States and U.S. Virgin Islands. No illnesses have been reported.

Serious·FDA·Sep 9, 2026

American Regent is recalling three lots of epinephrine injection (1 mg/mL multi-dose vials) due to leaking and cracked vials, plus contamination with particles including nylon, cellulosic, acrylic, polyethylene, and glass. These particles can block blood vessels, cause blood clots, and damage organs; cracked vials also risk loss of sterility and bacterial contamination. No adverse events have been reported so far.

Serious·FDA·Sep 3, 2026

GE is recalling four Portrait Core Services software products because a software issue may cause a loss of patient monitoring at the Hub and Central Viewer. After the update, alarm settings may also reset to factory defaults and no longer match the settings configured for each patient or care area. No injuries have been reported.

Serious·FDA·Sep 2, 20264 products

IMRIS is recalling 2 operating room table models, the ORT200 and ORT300, with 19 affected units. A mechanical failure in the linear actuator and rotational lock can stop the table from switching between locked and unlocked, which could allow unintended rotation during a procedure. No injuries have been reported.

Serious·FDA·Sep 2, 2026·IMRIS2 products

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

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

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

Seven loaner MiniMed 670G insulin pumps were cleaned with chemically incompatible products that may have damaged the pump casing or keypad. This damage could allow moisture inside the pump and cause it to deliver incorrect insulin doses — either too much or too little — which can lead to serious blood sugar swings.

Serious·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

Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.

Serious·FDA·Aug 26, 20262 products

BD Needle Kits used for emergency intraosseous (IO) access may have an obturator (the needle's internal plunger) that locks to the needle hub and becomes difficult or impossible to remove after placement. This locking is caused by out-of-tolerance manufacturing dimensions. If the obturator cannot be removed, a new needle may need to be placed, potentially delaying treatment.

Serious·FDA·Aug 26, 2026