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Alere is recalling four groups of hCG rapid tests, which detect the pregnancy hormone hCG, because they may pick up very low hCG levels below the stated sensitivity. This can lead to a false positive result. No injuries have been reported, and the tests were sold across the U.S. and in several other countries.

Moderate·FDA·Oct 7, 2026·Alere4 products

The bolus tracking application on Philips Spectral CT 7500 scanners (Software V5.2.x) can malfunction and continue taking imaging shots even after reaching the contrast threshold. This can cause patients to receive unintended additional radiation during CT scans.

Moderate·FDA·Oct 7, 2026

Illumina has issued a retrospective correction for certain NovaSeq 6000Dx and DRAGEN Server instruments used in genetic testing. These devices contain a security vulnerability in the server component that could potentially allow unauthorized access. This affects 80 instruments distributed worldwide.

Moderate·FDA·Oct 7, 2026·Illumina

Mastisol Skin Adhesive, a sterile surgical glue used in regional anesthesia procedures, is being recalled due to manufacturing issues with the product contained in surgical convenience trays. The recall affects a specific lot used in continuous epidural trays distributed nationwide.

Moderate·FDA·Oct 7, 2026·Custom Interventional Pain Management

ASP Global is recalling 64 Expressaire disposable tourniquet cuffs made between September 2016 and March 2023. The labels list a 10-year shelf life, but the validated shelf life is 5 years, so the printed expiration dates are wrong. No injuries have been reported.

Moderate·FDA·Oct 7, 2026·ASP Global64 products

A batch of benzoyl peroxide wash distributed by Rugby Laboratories has been found to contain microbial contamination. The affected product is a 5% benzoyl peroxide topical wash in a 5 fl oz bottle, lot #0525-02-345, expiring 02/2027, distributed in Illinois only.

Moderate·FDA·Oct 7, 2026·SV Labs2 products

Apotex Corp. is recalling Paroxetine Extended-Release Tablets 37.5mg (Lot# TY9495, Exp Date 05/2027) because they failed to meet dissolution specifications. This means the tablets may not break down properly in the body, affecting how much medicine is absorbed.

Moderate·FDA·Oct 7, 2026

Par Health USA and Endo USA are recalling certain lots of Buprenorphine Hydrochloride 0.3 mg/mL injection due to crystallization in the vials. Crystallization can affect the drug's effectiveness and safety. The recall affects six specific lots distributed nationwide.

Moderate·FDA·Oct 7, 2026

A shipment of Zoladex (goserelin) 3.6 mg implants was left in an unheated FedEx trailer in outdoor conditions for approximately 25.5 hours. This temperature exposure may have affected the medication's stability and effectiveness. The recall affects 296 cartons with lot number YN0099 (expiration 01/31/2028).

Moderate·FDA·Oct 7, 2026·TerSera Therapeutics

Amneal Pharmaceuticals is recalling specific lots of Estradiol Gel 0.1% because some packets in affected cartons were found to be empty or only partially filled. This means patients may not receive the correct dose of medication. The recall affects 2,592 cartons distributed nationwide.

Moderate·FDA·Oct 7, 2026

Glenmark Pharmaceuticals received complaints that some cans of Clindamycin Phosphate Foam 1% arrived damaged and were leaking. The affected product was distributed nationwide. No injuries have been reported.

Moderate·FDA·Oct 7, 2026

Ajanta Pharma USA Inc. is recalling one lot of Ranolazine Extended-Release Tablets, 1000 mg, because the tablets failed to meet dissolution specifications. This means the medication may not release properly in the body, potentially affecting its effectiveness. The recall affects lot DJ25134 with an expiration date of 11/30/2028, distributed nationwide.

Moderate·FDA·Oct 7, 2026

A software issue in the newest StatStrip Glucose Hospital Meter (Gen 2.0 model) can cause a glucose test result to be incorrectly linked to the wrong patient's medical record. When a patient ID barcode is scanned, previous patient information may stay on the meter screen; if a healthcare worker accidentally accepts it, the test result goes to the wrong patient, potentially leading to incorrect treatment decisions. One case of inappropriate insulin administration has been reported.

Moderate·FDA·Oct 5, 2026·StatStrip

Medline is recalling three convenience kits, 1,057 kits in total, because their neurological sponges may contain endotoxin levels that vary unpredictably. Elevated endotoxin can cause reactions such as fever, local inflammation, low blood pressure, or nausea, and may need medical care. No injuries have been reported.

Moderate·FDA·Sep 30, 20263 products

Baxter is recalling three PRO+ MRS mattress surface products, 999 units in total, because the product description on the Unique Device Identification (UDI) label contains errors. The mismatched labels could lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame. No injuries have been reported.

Moderate·FDA·Sep 30, 20263 products

Halyard IV START KIT NON-STERILE kits containing BD ChloraPrep Clear applicators may have open or incomplete seals on the applicator packaging. This affects 192 kits (4 cases) with lot number 1642214 and expiration date 7/31/2027. No injuries have been reported.

Moderate·FDA·Sep 30, 2026

New York Embroidery Studio's Trinity Non-Surgical Isolation Gown (Model NYES100-2, X-Large) does not consistently provide the liquid-barrier protection it should. This means the gown may allow fluids to pass through when it should block them, potentially exposing the wearer.

Moderate·FDA·Sep 30, 2026·New York Embroidery Studio

Intervascular's Cardioroot Woven Collagen Coated Vascular Graft failed to meet water permeability specifications in certain batches. The graft is a surgical implant used in vascular procedures. Approximately 16,329 units distributed worldwide are affected.

Moderate·FDA·Sep 30, 2026·Intervascular

During manufacturing quality testing, contamination in Baxter's test equipment may have affected the accuracy of nebulizer flow rate measurements on two VOLARA Homecare devices. The company has retrieved the affected units and retested them; both met specifications.

Moderate·FDA·Sep 30, 2026

DeRoyal Industries myocardial temperature probes (400 Series, Lot #63426754) contain an 18mm needle instead of the correct 15mm needle. This mismatch could affect proper placement and function during cardiac temperature monitoring.

Moderate·FDA·Sep 30, 2026·DeRoyal

Cardinal Health is recalling 2 groups of Presource Convenience Kits, totaling about 26,983 kits, because the applicators inside may have an open or incomplete seal on their packaging. A possibly contaminated applicator could cause no harm, or could lead to a localized skin or soft tissue infection, and less commonly a more widespread infection. The kits were distributed nationwide, with the recall covering stock sent to FL, KY, MO, NC, OH, and TX, and no injuries have been reported.

Moderate·FDA·Sep 30, 20262 products

Abiomed has issued a retrospective recall of certain Automated Impella Controller (AIC) units manufactured before 2019. The devices contain firmware and software defects that can affect the accuracy of pressure signals, cause unreliable placement detection, and trigger false alarms. These issues were remedied through firmware and software patches released in 2019.

Moderate·FDA·Sep 30, 2026

Becton Dickinson has recalled certain ForeSight Elite tissue oximetry cables due to incorrect labeling of Channel 1 and Channel 2 on the module and flag labels. This labeling error could cause clinicians to misread oxygen saturation data if the cables are connected to the wrong channels. The affected cables were distributed to hospitals and healthcare facilities.

Moderate·FDA·Sep 30, 2026

A software issue in Philips EPIQ Elite ultrasound systems (Model 795234, software version 14.0) causes doppler blood flow measurements to display at incorrect depths. This can lead to inaccurate velocity readings and potential misdiagnosis of vascular conditions. About 219 units are affected worldwide.

Moderate·FDA·Sep 30, 2026

A small number of Pearle Vision 1 day contact lenses in one affected lot were manufactured with incorrect lens power. This could result in blurred or distorted vision if the wrong lens is worn. No injuries have been reported.

Moderate·FDA·Sep 30, 2026·CooperVision

Olympus is recalling four BiCOAG Hemostasis Probe models because they may have been made without the full amount of adhesive, so the ceramic tip could detach. The recall covers 3,467 units sold in the US and several other countries. No injuries have been reported.

Moderate·FDA·Sep 30, 20264 products

Philips is recalling 12 groups of MRI systems and related upgrade products because of a software issue. If scan settings are manually adjusted so the image processing needs more memory than the system has, the examination can end partway through. No injuries have been reported.

Moderate·FDA·Sep 30, 202612 products

Some units of the Biomerieux VITEK 2 AST-N461 test kit used to determine antibiotic susceptibility in gram-negative bacteria have damaged card pouches. This damage can cause the test to report false resistant results, which may lead to use of less effective antibiotics or unnecessary antibiotic combinations.

Moderate·FDA·Sep 30, 2026

Medline convenience kits (models DYNJ48258D and DYNJ48258F) contain Healthmark Instrument Channel Brushes with a potential sharp edge or burr on the brush end. This sharp edge could cause a cut, abrasion, or infection if the brush is handled or used.

Moderate·FDA·Sep 30, 20262 products

SeaSpine Orthopedics is recalling certain Extended Polyaxial Head spinal implants (model MD1-300010-12) because the proximal thread depth does not meet design specifications. This defect could affect the secure attachment of the device during spinal surgery. No injuries have been reported.

Moderate·FDA·Sep 30, 2026