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Accriva Diagnostics' directCHECK ACT-LR whole blood quality control product (level 2, lot A6DLA001) has incorrect performance range information on its label. This labeling error could lead to misinterpretation of test results if the correct reference range is not known.

Moderate·FDA·Jun 24, 2026

AMD Medicom is recalling two Ritmed neurological sponge products used during brain and spine surgery. The sponges may not consistently meet the limit for endotoxin, a bacterial substance, in devices that contact cerebrospinal fluid. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·AMD Medicom2 products

Smith & Nephew identified a manufacturing error in certain TRIGEN Proximal Straight Humeral Nails (8/7 X 16, Ref: 71760816) in which the distal holes are missing. If implanted without detection, the affected nail could require revision surgery. Five units were distributed internationally.

Moderate·FDA·Jun 24, 2026·Smith & Nephew

Medtronic has identified a firmware anomaly in the O-arm O2 Imaging System detector panel that can cause image artifacts during surgical imaging. The issue affects specific serial numbers of the O-arm O2 model BI70002000. No injuries have been reported.

Moderate·FDA·Jun 24, 2026

Steris is recalling two surgical lighting systems, HarmonyAIR A-Series and ALYON, totaling about 2,650 units. The plus and minus buttons used to adjust light intensity on the light heads may detach. No injuries have been reported.

Moderate·FDA·Jun 24, 20262 products

Paint on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may chip or peel. This could potentially affect the lighting system's performance or introduce debris into the surgical field. The FDA has classified this as a Class II recall.

Moderate·FDA·Jun 24, 2026

Medline is recalling 34 convenience and procedure kits because they contain a recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. The adhesive's butyrate tubing may crack during use, making the product unusable for application. No injuries have been reported.

Moderate·FDA·Jun 24, 202634 products

Philips is recalling two imaging systems used in medical settings, the Allura Xper and MultiDiagnost Eleva, covering 2 product entries. The hand switch button may not fully release after use, which could cause loss of imaging function or unintended radiation exposure and extra contrast injection. No injuries have been reported.

Moderate·FDA·Jun 24, 20262 products

Dabur is recalling 14 antibiotic and antifungal creams, ointments and first aid products, including Lucky Super Soft, Circle K, Lil Drug Store, Rapidol, Cura Hongos and Med Pride. The FDA found manufacturing quality problems (CGMP deviations) during an inspection. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·Dabur14 products

Inventia Healthcare Limited's chlorthalidone 25 mg tablets failed to meet dissolution specifications, meaning the tablets may not break down properly in the body and deliver the full dose. This affects 100-tablet and 1000-tablet bottles distributed nationwide. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·Inventia Healthcare

Keystone Industries is recalling 7 topical anesthetic gels containing 20% benzocaine, sold as Pearson Quality, Quala, DHP, Burkhart, Dental City, PureLife, and safco SensiCaine-Ultra. The recall is due to a container defect: some bottles may have incomplete seals. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·Keystone Industries7 products

Par Health USA's buprenorphine HCl injection (0.3 mg/mL) has been found to contain crystallization identified as buprenorphine free base in certain lots. This affects vials distributed nationwide. The FDA has classified this as a Class II recall.

Moderate·FDA·Jun 24, 2026

IntegraDose Compounding Services LLC is recalling Vasopressin 2 Units/2 mL syringes because the drug may contain less active ingredient than labeled. This affects two specific lots distributed nationwide. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·IntegraDose

VistaPharm is recalling four sizes of Kerr Insta-Char activated charcoal with cherry flavor, in aqueous and sorbitol bases. The product did not meet the FDA over-the-counter monograph M023 standard. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·Pain Train Salsa4 products

Glenmark Pharmaceuticals is recalling specific lots of Alyacen 7/7/7 (a birth control pill) because testing found higher-than-allowed impurity levels in the tablets. The affected lots were distributed nationwide. No injuries have been reported.

Moderate·FDA·Jun 24, 2026

Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.

Moderate·FDA·Jun 17, 2026

AVID Medical is recalling four Halyard kit types because sealed pouches were distributed without validated sterilization. The kits may not be sterile, and the recall includes 476 kits total, distributed in Iowa. No injuries have been reported.

Moderate·FDA·Jun 17, 20264 products

Elekta's MOSAIQ Oncology Information System software (version 3.2) may fail to load an adapted baseline shift plan during cancer treatment delivery if a communication error occurs. This could affect the accuracy of radiation therapy positioning. No injuries have been reported.

Moderate·FDA·Jun 17, 2026

Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.

Moderate·FDA·Jun 17, 2026

Boston Scientific is recalling the Model SC-4318 Clik X Anchor (Lot #35107836) because sterile anchors may lack proper sterility assurance. Approximately 43 units were distributed across six U.S. states.

Moderate·FDA·Jun 17, 2026

Boston Scientific is recalling two lines of reusable electrodes, CSK and TCN, because they may not meet expected performance levels. The recall covers 2 products with about 81,000 units total, distributed across the US and several other countries. No injuries have been reported.

Moderate·FDA·Jun 17, 20262 products

Fresenius Medical Care's Bicarby Dialysate (Model RFP-400-G) has incorrect barcode labeling on some units. While the case label and printed information are correct, scanning the GTIN barcode alone could lead to identification errors. This could result in use of a dialysate with a potassium concentration different from what was prescribed.

Moderate·FDA·Jun 17, 2026

Some units of Inter-Med's Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit (catalog 504600-28) contain the package insert for Ferric Sulfate Gel instead. The wrong insert gives incorrect first aid instructions—specifically, it tells users to induce vomiting if the gel is swallowed, when the correct instructions say not to induce vomiting.

Moderate·FDA·Jun 17, 2026·Inter-Med

DT MedTech discovered that some Hintermann Series Talar Implant units labeled as left implants actually contained right implants inside the packaging. This mix-up was found through customer complaints. A total of 67 units across five US states and two countries are affected.

Moderate·FDA·Jun 17, 2026·DT MedTech

Three lots of Siemens Dimension Tacrolimus Flex Reagent Cartridges show a potential positive bias in quality control and patient test results. This means the cartridges may report tacrolimus levels that are higher than actual values. The affected lots are FA6254, FA6260, and FA6286.

Moderate·FDA·Jun 17, 2026

The EXENT Analyser, an automated blood-test device, has a software issue where certain test plates were marked as passed without performing required quality checks. This could allow inaccurate M-protein measurements—either missed detections or wrong concentration values—to be reported to clinicians.

Moderate·FDA·Jun 17, 2026·The Binding Site

Medartis has recalled certain APTUS 5.0 headed cannulated compression screws (CCS) used in bone fixation surgery because the central hole in the screw is not properly centered. This affects 13 units across five states. No injuries have been reported.

Moderate·FDA·Jun 17, 2026·Medartis

Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98-16mm zirconium oxide discs used in dental crowns and bridges. Some discs may have a reduced or missing dentin layer, which can weaken them and cause fractures when patients chew or bite.

Moderate·FDA·Jun 17, 2026·Sagemax

In2bones USA has recalled NeoSpan SuperElastic Compression Staples used in hand and foot surgery because the required Magnetic Resonance Imaging (MRI) safety symbol is missing from the product packaging, inner trays, and patient labels. This labeling omission could prevent patients and healthcare providers from knowing whether the implant is safe to use during an MRI scan.

Moderate·FDA·Jun 17, 2026·In2bones

One Philips DigitalDiagnost C90 Flex/Value/Chest/ER X-ray system was shipped without the required Seismic kit for its Wall Stand VS2. The kit is designed to keep the stand stable and prevent damage during earthquakes or seismic events.

Moderate·FDA·Jun 17, 2026