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  • Pentax ultrasound endoscopes need updated instructions for deaerated water

    Pentax of America added warnings to the instructions for use for certain PENTAX Medical ultrasound endoscopes and their water bottle assemblies. The warnings ask users to make sure deaerated sterile water is in the assembly before and during each procedure. The recall covers 84 units of model EG36-J10UR, all serial numbers, and no injuries have been reported.

    ModerateFDAOct 28, 2026Pentax5 products

  • Eagle Pharma phenylephrine and oxytocin infusions recalled for sterility risk

    Eagle Pharma Outsourcing is recalling two compounded IV infusion products nationwide: phenylephrine HCl (100 mg in 250 mL saline, 50 containers) and oxytocin (30 units in 500 mL saline, 5 containers). The company cannot assure that the products are sterile. No injuries have been reported.

    ModerateFDAOct 28, 2026Eagle Pharma Outsourcing2 products

  • H-E-B Chop Salad kit recalled for undeclared soy and almonds

    Taylor Farms is recalling H-E-B Backyard BBQ Chop Salad Kit (13.4 oz) because it may contain soy and tree nuts (almonds) that are not listed on the label. People with a soy or almond allergy could have a serious reaction if they eat it. No reactions have been reported so far.

    ModerateFDAOct 27, 2026

  • Medtronic CareLink SmartSync devices recalled for software estimate error

    Medtronic is recalling three CareLink SmartSync products, including the programmer, RF head patient connector and Device Manager app, because a software problem can cause an inaccurate displayed longevity estimate for implanted pulse generators. No injuries have been reported. The recall covers about 61,000 units distributed worldwide.

    ModerateFDAOct 27, 20263 products

  • BioMerieux EMAG system recalled for software error delaying results

    BioMerieux is recalling a limited number of EMAG nucleic acid sample preparation instruments used in clinical labs. After updating to firmware SP4 Patch 2, a random software error (Error 10003, Heater timeout) can cause delayed or no results when analyzing clinical samples. No injuries have been reported.

    ModerateFDAOct 27, 2026

  • Philips Azurion imaging systems recalled for unapproved SSD risk

    Philips is recalling 9 Azurion imaging system models, including Azurion 3, 5, 7 and S configurations. Some of these PCs may contain solid-state drives (SSDs) that are not specified in the Medical Device File, which could lead to reduced reliability over time, such as loss of imaging, a blank or black display, or trouble storing or accessing images. No injuries have been reported. The recall covers units distributed in the US and many other countries.

    ModerateFDAOct 27, 20269 products

  • Canon Alphenix angiography systems recalled for software error

    Canon Medical Systems is recalling 15 Alphenix interventional angiography X-ray systems (model INFX-8000C). A software issue can cause an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use. The systems were distributed to hospitals and facilities in 18 states.

    ModerateFDAOct 27, 20263 products

  • Fei Fah Electric Medicated Balm recalled for manufacturing quality issues

    Fei Fah Medical Manufacturing recalled its Ultra Strength Electric Medicated Balm because it did not meet FDA manufacturing quality standards (CGMP). The recall covers about 171,120 units sold nationwide in 70g and 10g sizes. No injuries have been reported.

    ModerateFDAOct 27, 2026Fei Fah Medical Manufacturing

  • Palm, Lynx, PRO CHEM and more soaps recalled for manufacturing issues

    ABC Compounding Co. is recalling 19 antiseptic hand soap, antiseptic foam and hand-and-body wash products nationwide. The recall cites manufacturing practice violations (cGMP deviations), and no injuries have been reported. The products come from several makers and sellers, including ABC Compounding, and are sold under names such as Palm, Lynx, Aero Foamy, PRO CHEM and Chemseptic.

    ModerateFDAOct 27, 2026ABC Compounding19 products

  • Philips Model 712010 device recalled for failure risk

    Philips North America has recalled Model 712010 devices due to a potential for the device to fail immediately after exposure, which could cause the system to stop working. Approximately 563 units are affected.

    ModerateFDAOct 26, 2026

  • ValuHealth acetaminophen recalled for mismatched bottle label

    ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg bottles have an incorrect label on the bottle itself. The outer carton correctly says "Acetaminophen 500 mg," but the label on the bottle says "Pain Relief PM" — a different product. This mismatch could cause confusion about what you're taking.

    ModerateFDAOct 26, 2026Prodose

  • Huons lubricant eye drops recalled for plastic contamination

    Huons carboxymethylcellulose sodium lubricant eye drops in single-use containers were found to contain a plastic-related compound (polyethylene leachable) at levels above acceptable limits. The contamination was detected during quality testing. Affected lots have expiration dates ranging from March 2027 to October 2028.

    ModerateFDAOct 26, 2026Huons

  • Strides Pharma Cinacalcet tablets recalled for dissolution failure

    Strides Pharma is recalling one lot of Cinacalcet 30 mg tablets because they failed to meet dissolution specifications, meaning the tablets may not break down properly in the body. This could result in inconsistent or reduced drug effectiveness. The affected lot is 7717825A, expiring 11/30/2028.

    ModerateFDAOct 26, 2026Strides

  • Macleods Pharma blood pressure tablets recalled for dissolution failure

    Macleods Pharma USA is recalling specific lots of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide combination tablets (40 mg/10 mg/12.5 mg) because they failed to meet dissolution specifications. This means the tablets may not break down properly in the body, potentially reducing how well the medication works.

    ModerateFDAOct 26, 2026

  • Ziehm Orthoscan VERSA cart recalled for monitor arm separation

    Certain Ziehm Orthoscan VERSA accessory carts and Versa Mini C-Arm systems have welds that do not meet specifications. This defect could cause the monitor arm mounting structure to separate from the cart during use.

    ModerateFDAOct 23, 2026Ziehm Imaging

  • Medtronic OmniaSecure lead recalled for implant fixation difficulty

    Medtronic has recalled certain OmniaSecure Model 3930M ventricular leads (used in heart devices for pacing and defibrillation) due to reports of difficulty achieving proper fixation during implantation. This implantation difficulty could potentially cause tissue trauma during the surgical procedure.

    ModerateFDAOct 23, 2026

  • Ethicon ETHILON Nylon Suture recalled for defective needles

    Some ETHILON Nylon Suture needles have distorted curvature and may break during surgical use. This could cause additional injury to soft tissue or blood vessels, including tearing or bleeding during surgery.

    ModerateFDAOct 23, 2026Ethicon

  • Hikma Abirtega recalled for tablet weight uniformity failure

    Hikma Pharmaceuticals is recalling Abirtega (abiraterone acetate) 250 mg tablets due to failed weight uniformity specifications. Lot 3047 (expiring July 2027) does not meet quality standards. The issue was identified during quality testing; no injuries have been reported.

    ModerateFDAOct 23, 2026Hikma Pharmaceuticals

  • Safecor Health metoclopramide tablets recalled for co-mingled contamination

    Safecor Health is recalling specific batches of metoclopramide 5 mg tablets manufactured for Teva Pharmaceuticals due to co-mingled tablets in the bottles. Co-mingling means tablets from different batches or products may have been mixed together. The affected lot is 3116509 with an expiry date of 07/31/2027.

    ModerateFDAOct 23, 2026

  • Glenmark Abiraterone Acetate tablets recalled for labeling issue

    Glenmark Pharmaceuticals is recalling Abiraterone Acetate Tablets USP 500 mg in 60-count bottles due to a labeling defect. The affected lot (13250135, expiring 11/2027) was distributed nationwide. No injuries have been reported.

    ModerateFDAOct 23, 2026

  • Ritedose Formoterol Fumarate inhalation solution recalled for impurity concerns

    Ritedose Pharmaceuticals recalled one lot of Formoterol Fumarate Inhalation Solution (20mcg/2mL) because it failed quality testing for impurities and degradation. The affected lot (25BL0, expiring 02/28/2027) was distributed nationwide. No injuries have been reported.

    ModerateFDAOct 23, 2026Ritedose

  • Halyard ANTERIOR HIP PACK recalled for non-sterile component

    Halyard ANTERIOR HIP PACK surgical kits (model SOAH31) contain a component that was not properly sterilized before packaging. The component was placed outside the sterile barrier and did not receive the required sterilization treatment. This affects 56 kits distributed in Arizona with lot number 1689215 and expiration date 11/06/2026.

    ModerateFDAOct 22, 20262 products

  • Medline drapes and convenience kits recalled for adhesive residue

    Medline is recalling 13 surgical drape and medical convenience kit products because the adhesive can be difficult to remove from patients and may leave residue on the skin. No injuries have been reported. The recall covers US nationwide distribution and several other countries.

    ModerateFDAOct 22, 202613 products

  • Solstice Xact mole marker recalled for detaching material

    The radiopaque (X-ray visible) material on the Xact mole marker can detach during use. When this happens, the loose material may create artifacts (unwanted marks or shadows) on mammography images, potentially affecting image quality and interpretation.

    ModerateFDAOct 22, 2026Solstice

  • Medtronic InterStim leads and extensions recalled for wrong parts

    Medtronic is recalling two product groups in its InterStim system: InterStim SureScan MRI leads and InterStim percutaneous extensions. The recall covers 2 products in total. The company says the wrong lead or extension may have been selected, and an incompatible one may stop the system from working as intended. This could delay surgery or require surgical replacement of the product. No injuries have been reported.

    ModerateFDAOct 22, 20262 products

  • Medtronic MiniMed Go App recalled for failed dose reminders

    A software bug in MiniMed Go version 1.2.1 broke the long-acting insulin dose reminder feature for users who had it enabled in earlier versions. When users updated the app, the reminder stopped working silently—without any alert to the user. This could cause users to miss or delay insulin doses, or accidentally take a double dose if they're unsure whether they already dosed.

    ModerateFDAOct 22, 2026

  • restor3d MTP Implant recalled for non-sterile units

    Sixteen restor3d MTP foot implants were distributed without proper sterilization. The implants showed orange sterilization indicators, meaning they were never exposed to the sterilization process required to make them safe for surgery. These implants are used to treat arthritis and other conditions in the big toe joint.

    ModerateFDAOct 22, 2026

  • Boston Scientific Direxion microcatheters recalled for coating defect

    Boston Scientific is recalling 41 Direxion Torqueable Microcatheter models. The hydrophilic coating on the outer tip may not have been fully cured, and some nitinol sleeves have raised ridges caused by laser-cutting misalignment. No injuries have been reported.

    ModerateFDAOct 22, 202641 products

  • Ion Torrent Genexus Dx sequencer software has security vulnerabilities

    The Ion Torrent Genexus Dx DNA/RNA sequencing system software (version 6.8.2.1 and earlier) contains security vulnerabilities that could potentially be exploited. Life Technologies has identified 16 affected sequencers across multiple U.S. states.

    ModerateFDAOct 22, 2026Life Technologies

  • CooperVision contact lenses recalled for incorrect wear labeling

    Certain batches of CooperVision Softmed Breathables Advanced Toric contact lenses have incorrect packaging labels stating they are approved for extended wear. These lenses are designed and FDA-approved for daily wear only, not extended wear. The mislabeling could lead users to wear the lenses longer than intended.

    ModerateFDAOct 22, 2026CooperVision

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