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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

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

Pfizer has recalled one lot of Dopamine HCl injection (40 mg/mL) distributed nationwide due to a lack of assurance of sterility. The affected lot is NL5230, with an expiration date of October 2027. This is a precautionary measure to ensure patient safety.

Moderate·FDA·Sep 23, 2026·Pfizer

Inventia Healthcare Limited's chlorthalidone 25 mg tablets (batch RISA24002, expiring 04/2027) failed to meet dissolution specifications, meaning the tablets may not break down properly in the body. This could affect how well the medication works. About 13,567 bottles were distributed nationwide.

Moderate·FDA·Sep 23, 2026·Inventia Healthcare

Taro Pharmaceuticals is recalling one lot of Lidocaine Ointment USP 5% because testing found the active ingredient strength was outside acceptable limits. The affected lot was identified during long-term stability testing. No injuries have been reported.

Moderate·FDA·Sep 23, 2026

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 2.5 mg per 5 mL because they failed stability testing, meaning the medication may not maintain its strength or safety over time. The affected lots were distributed nationwide.

Moderate·FDA·Sep 23, 20266 products

Sun Pharmaceutical is recalling specific lots of Nystatin Cream, USP (15 g tubes) because the medication failed stability testing. This means the cream may not maintain its expected strength or safety over time. The affected lots are AD49605 and AD49606, with expiration dates of 05/31/2027.

Moderate·FDA·Sep 23, 2026

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

Bard is recalling six Foley and intermittent catheter tray products because the pericare wipes packed with them may have contamination on their surface. The recall followed customer complaints, and no injuries have been reported. The trays were distributed across the United States and in several other countries.

Moderate·FDA·Sep 16, 20266 products

Atrium Medical is recalling three Getinge PVC thoracic catheter products, covering 11 model sizes, from a single lot. Testing found bacterial endotoxin levels above the allowed limit. No injuries have been reported.

Moderate·FDA·Sep 16, 2026·Atrium Medical3 products

Lutronic's DermaV laser system may produce sparks and loud noise when used at higher energy levels (fluences) at the 1064 nm wavelength with current cooling settings. This spark hazard could result in patient burns during treatment.

Moderate·FDA·Sep 16, 2026

Halyard IV Start Kit Non-Sterile (REF: KRIV26-02) convenience kits contain BD ChloraPrep Clear and FREPP Clear applicators with wrinkles in the paper lidding that may breach the seal. This compromises sterility assurance of the applicators. 98 kits in lot 1658438 (expiration 7/31/2026) were distributed nationally.

Moderate·FDA·Sep 16, 2026

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

OurPharma LLC's fentanyl citrate 1,000 mcg injection solution has conflicting expiration dates printed on the IV bag and product labeling. The bag shows expiry dates of 07/31/2026 or 11/30/2026, while the product itself is labeled as expiring 12/09/2026. This discrepancy could lead to confusion about when the medication is safe to use.

Moderate·FDA·Sep 16, 2026·OurPharma

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

Ajanta Pharma USA Inc. is recalling fluphenazine hydrochloride 1mg tablets (NDC 27241-255-01) because stability testing at 18 months found organic impurity levels slightly above specification limits. The tablets contained 1.1% of Impurity-A, exceeding the 1.0% specification. No injuries have been reported.

Moderate·FDA·Sep 16, 2026

ImprimisRx NJ LLC is recalling specific lots of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution used in medical offices because the medication contains lower-than-intended active ingredients. The affected lots may not work as intended for their intended use.

Moderate·FDA·Sep 16, 2026·ImprimisRx

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

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

Moderate·FDA·Sep 9, 202612 products

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

Moderate·FDA·Sep 9, 20263 products

Specific lots of B Braun's Discofix Four Way Stopcock extension sets have an incorrect expiration date printed on the carton shipper label. This labeling error could affect proper product tracking and usage verification.

Moderate·FDA·Sep 9, 2026

A software issue in the robotic controller of the Medos Velys Enabling Tech Robotic-Assist Station may cause the robotic arm to move unexpectedly during bone preparation or instrument positioning in orthopedic surgery. This affects 29 devices nationwide.

Moderate·FDA·Sep 9, 2026·Medos