Check a product

Certain lots of Dexcom G7 continuous glucose monitoring sensors that were designated for destruction were stolen and later sold to pharmacies and distributors without authorization. Two affected lots have different risks: one was not properly sterilized and poses an infection risk, and the other may not provide accurate readings or detect dangerous blood sugar levels.

Moderate·FDA·Jul 1, 2026

Surgify Medical is recalling 19 Surgify Halo drill burr products used in bi-portal endoscopic spinal surgery because the burrs may break during use. The recall was filed as a Class II device recall, and no injuries have been reported. The products were distributed nationwide, including to MN, MA, IN, LA, CA, NY, and FL.

Moderate·FDA·Jul 1, 2026·Surgify Medical19 products

A software issue in the Thuvera Laser Console (Software Version 2.2) causes the device to display a false error code 5018. This anomaly may lead clinicians to misinterpret the device status during operation.

Moderate·FDA·Jul 1, 2026·IPG Medical

GE Healthcare's AW Server 3.2 ext.6.5 has a software issue that can cause the system to display a previous patient's medical images instead of the correct patient's images when launching certain applications. There is no warning or error message when this happens. If a radiologist or clinician does not notice the error, they could misread images, make wrong diagnoses, or recommend incorrect treatment.

Moderate·FDA·Jul 1, 2026

Stryker Neurovascular's INZONE Detachment System devices may experience premature battery drain, causing them to fail to power on, display faint indicators, or be unable to detach an embolization coil as intended. If a device fails during a procedure, medical staff may need to use an alternative technique to complete the intervention.

Moderate·FDA·Jul 1, 2026

Acumed Hexalob Screws used in wrist fixation systems may break during use due to a manufacturing error. The affected screws come in various sizes (2.7mm and 3.0mm) and have been distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·Acumed

Zimmer Biomet is recalling five Off-Axis shoulder system reamer guide products distributed nationwide. The company received five complaints that the plastic guides caught during reaming and broke. No injuries have been reported.

Moderate·FDA·Jul 1, 20265 products

PFM Medical's Multi-Snare Set catheters (5 mm and 10 mm models) failed to meet biocompatibility safety standards. If used, the device material could cause localized inflammation and tissue irritation when in contact with blood vessels.

Moderate·FDA·Jul 1, 2026·PFM Medical

TMJ Solutions Inc. has recalled one custom temporomandibular joint implant (model CHG020) that may contain incorrect patient-specific components. The mismatch caused a poor fit, resulting in a right-sided open bite for the affected patient.

Moderate·FDA·Jul 1, 2026·TMJ Solutions

Philips is recalling two Avalon fetal monitor models, the FM20 and FM30, because the speaker connector may have been assembled incorrectly. Device cables can be pulled out of the housing, which may cause intermittent or permanent loss of speaker output. The recall includes 454 affected units, and no injuries have been reported.

Moderate·FDA·Jul 1, 20262 products

Sun Pharmaceutical discovered that some bottles labeled as containing 6mg Perampanel tablets actually contained 10mg tablets instead. This mix-up affects one lot (AE01763) distributed nationwide. Patients taking the wrong strength could receive an incorrect dose of this seizure medication.

Moderate·FDA·Jul 1, 2026

Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic does not contain the full strength stated on the label. Five specific production lots distributed nationwide do not meet the required potency standard, which means the product may not work as intended for oral antiseptic purposes.

Moderate·FDA·Jul 1, 2026·Elevate Oral Care

Some bottles of Lacosamide 100mg tablets may contain Selexipag 1000 mcg tablets instead. This mix-up happened during manufacturing and could cause patients to take the wrong medication. The recall affects specific lots distributed nationwide.

Moderate·FDA·Jul 1, 2026·Annora Pharma

CareFusion is recalling four sizes of BD ChloraPrep Clear and BD ChloraPrep FREPP Clear skin antiseptic applicators because wrinkles in the paper lid may break the seal, so the products may not stay sterile. No injuries have been reported. The products were distributed nationwide in the U.S. and to other countries.

Moderate·FDA·Jul 1, 20264 products

PReye LLC is recalling all lots of PReye Vitamin See Antioxidant Preservative Free Eye Drops due to lack of assurance of sterility. The recall affects approximately 50 to 60 bottles distributed in Colorado. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·PReye

ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·ANI Pharmaceuticals

Direct Rx's packaged Duloxetine D/R 30 mg capsules contain levels of N-nitroso-duloxetine, a potentially harmful impurity, above FDA's recommended limit. This is a manufacturing quality issue affecting specific lots distributed nationwide.

Moderate·FDA·Jul 1, 2026·Direct Rx

Amgen is recalling five bottle sizes of two prescription heart and thyroid-related drugs, Corlanor (ivabradine) and Sensipar (cinacalcet), because the tablets may contain a foreign substance. The products were distributed nationwide, and no injuries have been reported.

Moderate·FDA·Jul 1, 2026·Amgen5 products

Ajanta Pharma USA Inc. is recalling one lot of fenofibrate 200 mg capsules due to manufacturing quality deviations discovered during inspection. The affected lot (PA02216, expiring 12/2029) was distributed nationwide.

Moderate·FDA·Jul 1, 2026

MAJOR Pharmaceuticals is recalling Methylergonovine Maleate Tablets, USP, 0.2 mg due to subpotency — meaning the tablets contain less active ingredient than labeled. The affected lots were distributed nationwide. This is a prescription medication used to control bleeding after childbirth.

Moderate·FDA·Jul 1, 2026

The HeartMate 3 System Controller, which powers and monitors left ventricular assist devices (LVADs), may experience failures in its 11-volt backup battery. This backup battery is critical for emergency power when other power sources are unavailable.

Moderate·FDA·Jun 24, 20263 products

Merit Medical Systems' Splashwire Hydrophilic Guide Wire — used by doctors in vascular procedures — has been recalled because some product pouches were not sealed properly. Unsealed pouches can allow contamination or damage to the sterile device before use.

Moderate·FDA·Jun 24, 2026

Inspire Medical Systems is recalling two implant lead products, the Respiratory Sensing Lead and the Stimulation Lead, because they carry a Use By Date that goes beyond their validated three-year shelf life. The agency says material can degrade past the labeled date, which may lead to unplanned or premature revision surgery. No injuries have been reported.

Moderate·FDA·Jun 24, 2026·Inspire2 products

BD Connecta BD Luer-Lok 360 stopcocks used to administer IV fluids and medications may have a connection problem at Port C. When a plastic luer-lok syringe is attached, the connection may over-thread or continue spinning instead of tightening securely, making it feel unstable.

Moderate·FDA·Jun 24, 2026

A firmware bug in the iLet Bionic Pancreas can cause the lock screen to fail to unlock when users slide the unlock slider. When this happens, users become stuck on the lock screen and cannot change insulin cartridges or enter meal information. The pump will continue delivering insulin until the cartridge empties and the battery drains, which may lead to high blood sugar.

Moderate·FDA·Jun 24, 2026·Beta Bionics

Staar Surgical's ICL Calculation Software Version 8.00 contains a coding error that can produce incorrect implantation orientation diagrams for toric intraocular lenses. The error occurs when multiple toric lens calculations are generated for the same eye between April 13–16, 2026. An incorrect diagram could lead to improper lens alignment during surgery.

Moderate·FDA·Jun 24, 2026·Staar Surgical

Medline recalled 30 products, including urethral catheters, catheterization trays, intermittent latex catheters, and medical procedure kits. During an internal review, the company found that some samples did not meet performance specifications, including surface irregularities, connectors that detached early from the catheter funnel, and some catheters with outer diameters outside specification. No injuries have been reported.

Moderate·FDA·Jun 24, 202630 products

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed infant beds. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners disengaging could cause the canopy soffit to loosen or detach entirely.

Moderate·FDA·Jun 24, 20263 products

ConMed is recalling 11 AirSeal access port and obturator products used in minimally invasive (laparoscopic) surgery. The recall is for a potential problem that could cause overpressure alerts during procedures. No injuries have been reported, and the products were distributed nationwide and internationally.

Moderate·FDA·Jun 24, 2026·ConMed11 products

Stryker identified that some Triathlon Universal Baseplate Size 3 units (lot UZD9IB) were packaged in boxes labeled as Size 4, while Size 4 units (lot TYX7OB) were packaged in boxes labeled as Size 3. This labeling mix-up could result in using the wrong implant size during surgery.

Moderate·FDA·Jun 24, 20262 products