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A software defect in Beckman Coulter's DxC 500 AU Clinical Analyzer (software version 1.5 or lower) can silently overwrite customized test calculation rules when a new Parameter Package is imported. This may cause the analyzer to generate incorrect patient test results without alerting the operator to the problem. The issue only occurs when updating an existing system; newly installed systems are not affected.

Moderate·FDA·Aug 26, 2026

Paragon 28 is recalling two custom-made navicular cage foot implants because their oxygen level is above the allowed limit. Elevated oxygen may reduce the metal's ductility, meaning it may be less able to bend before breaking. The devices were distributed across the US, and no injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

The Blanketrol II Model 222S thermal regulating system may experience overheating of its 115V CPU board, which can cause the device to shut down unexpectedly. This affects 182 units distributed worldwide. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Gentherm Medical

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

Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.

Moderate·FDA·Aug 26, 2026

Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

The battery mounting tabs in some TD Navio Midi speech-generating devices may become damaged, allowing the battery to shift inside the device. This can cause an internal short circuit, leading to localized heating and gas venting inside the device enclosure.

Moderate·FDA·Aug 26, 2026

The ARVIS Surgical Navigation System Gen 2, a computer-controlled device used by surgeons to help position orthopedic implants during knee, hip, and shoulder surgery, has a sensor issue that can cause the image displayed through the eyepiece to appear tilted. This misalignment could affect the accuracy of surgical guidance if the surgeon relies solely on the displayed image without cross-checking with other alignment methods.

Moderate·FDA·Aug 26, 2026·Kico

The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 20262 products

Intersurgical is recalling two sizes of its One-Piece Guedel Airway, a device used to keep a patient's airway open. The devices could be blocked or partly blocked, and about 22,844 units are affected. They were distributed nationwide, with US distribution in CT, FL, IN, MI, OH, and VA, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Intersurgical2 products

Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.

Moderate·FDA·Aug 26, 2026

The EndoFLIP endoscopic measuring system has a 24-hour usage limit that causes catheters to be incorrectly marked as expired. This prevents catheters from being used in clinical procedures even though they may still be suitable for use.

Moderate·FDA·Aug 26, 2026

Spectral Instruments is recalling 75 units across two products: 40 Lago X and 35 Ami HTX. The on-screen "X-Ray On" banner can briefly be absent during the run readiness check. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Spectral Instruments2 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

American Regent is recalling 12 injectable and oral solution products, including nitroglycerin, cyanocobalamin (vitamin B12), aminocaproic acid, atropine, acetylcysteine, selenious acid, papaverine, niCARdipine, and the trace element products Multrys and Tralement. Some vials may contain particulate matter identified as hair, glass, and/or paraformaldehyde. No injuries have been reported.

Moderate·FDA·Aug 26, 202612 products

Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.

Serious·FDA·Aug 26, 2026

Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.

Moderate·FDA·Aug 26, 2026

Golden State Medical Supply is recalling Carbamazepine Tablets, USP 200mg due to black specks found in some tablets. This is a manufacturing quality issue. The affected lots were distributed nationwide.

Moderate·FDA·Aug 26, 2026

Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.

Moderate·FDA·Aug 26, 2026

Regeneron is recalling one lot of Libtayo (cemiplimab-rwlc), an intravenous cancer treatment, because the manufacturer cannot guarantee the vials are sterile. This affects lot 8494000002, which expires July 31, 2028. About 21,353 vials are involved in the recall nationwide.

Moderate·FDA·Aug 26, 2026·Regeneron

Certain vials of PEMRYDI RTU (pemetrexed injection) have developed green to dark green discoloration. The affected lots are P400172 and PA00050A, expiring 09/30/2027. Discoloration may indicate a quality issue with the medication.

Moderate·FDA·Aug 26, 2026·Shilpa Medicare2 products

Vitruvias Therapeutics is recalling one lot (504950) of Thyroid Tablets, USP 30 mg because testing found the tablets may contain higher-than-intended amounts of thyroid hormone. Taking overly potent thyroid medication can cause an overactive thyroid, leading to weight loss, rapid heartbeat, chest pain, and other serious symptoms, especially in elderly people, pregnant women, and infants.

Moderate·FDA·Aug 21, 2026·Vitruvias Therapeutics

Optimal Balance Pharmacy identified elevated bacterial endotoxin levels in one lot of compounded glutathione 200 mg/mL multi-dose vials during testing. Endotoxins can cause fevers, low blood pressure, severe allergic reactions, and in serious cases, death. The pharmacy has already received reports of adverse events including fever, chills, severe headache, nausea, vomiting, and allergic-like reactions.

Serious·FDA·Aug 19, 2026·Optimal Balance Pharmacy

Baxter Healthcare Corporation is recalling one lot of Cefazolin in Dextrose injection due to the presence of particulate matter in the solution. The affected product is a frozen premix infusion bag used for intravenous antibiotic treatment. This is a Class I recall, the most serious classification.

Serious·FDA·Aug 19, 2026

Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (ioversol injection 74%, 350 mg/mL) due to the presence of particulate matter—including plastic, stainless steel, and glass—found in affected vials. The contamination affects lot #25ZF3670 with an expiration date of May 31, 2027, distributed nationwide in the US and Mexico.

Serious·FDA·Aug 19, 2026·Liebel-Flarsheim

Victory Medical Center Pharmacy's Glutathione injectable solution (200 mg/mL) failed sterility testing and was found to contain elevated bacterial endotoxin levels, which are out of acceptable limits. The affected product was distributed nationwide in specific lots with expiration dates through August 2026.

Serious·FDA·Aug 19, 2026·Victory Medical Center Pharmacy

Heritage Pharmaceuticals' clindamycin palmitate hydrochloride oral solution (75 mg/5 mL) has been recalled due to the presence of particles and white flakes found in reconstituted bottles. The affected lot is 2411550, which expires November 2026. This product was distributed nationwide.

Moderate·FDA·Aug 19, 2026·Heritage Pharmaceuticals

CLEAR EYES Maximum Itchy Eye Relief eye drops may not be sterile due to potential contamination. The affected product is the 0.5 fl oz (15 mL) dropper bottle, Lot 2552A with expiration date 09/30/2027. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Prestige Brands

Shoolin Pharma Chem LLP is recalling five bulk powder products, sildenafil citrate and tadalafil in 100-gram, 500-gram, and 1-kilogram sizes, sold for prescription compounding only. The recall was triggered by manufacturing practice (CGMP) deviations found during an FDA inspection, and no injuries have been reported. The products were distributed nationwide.

Moderate·FDA·Aug 19, 2026·Shoolin Pharma Chem5 products

Apollo Care is recalling 11 strengths of semaglutide sterile multi-dose vials for subcutaneous injection, all sold under the APOLLO care brand. The vials may contain particles identified as nylon/polyamide and silk-like material. The recall covers products distributed nationwide, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Apollo Care11 products