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Stability testing found that ammonia (NH4+) measurements in specific lots of this quality control material drift over time, making the labeled shelf-life claim unreliable. Labs using affected lots may get delayed or inaccurate results, which could delay diagnosis of dangerously high ammonia levels that need urgent treatment.

Moderate·FDA·Oct 22, 2026·Techno-Path Manufacturing3 products

Medline distributed surgical convenience kits containing cannula components that do not meet international safety standards. These components may leak or break during cardiac, vascular, and transplant procedures.

Moderate·FDA·Oct 21, 202612 products

Carolina Infusion LLC of Ridgeland, SC, is recalling 16 compounded injectable products sold as tirzepatide, semaglutide, semaglutide/cyanocobalamin, tirzepatide/cyanocobalamin, sermorelin, Quad-Mix, and Tri-MIX. The company cannot assure that the products are sterile, which relates to the bacteriostatic water used in the formulation and the processing equipment. No injuries have been reported.

Moderate·FDA·Oct 14, 2026·Carolina Infusion16 products

K.C. Pharmaceuticals sterile eye drops (tetrahydrozoline HCl 0.05%) sold under multiple store brands including Best Choice, Good Sense, H.E.B., Walgreens, and others may not meet sterility standards. The product was distributed nationwide in 0.5 fl oz bottles.

Moderate·FDA·Oct 14, 20268 products

HeartSine distributed certain models of samaritan PAD defibrillators without a required Maintenance Supplement document. This document provides instructions for an additional quarterly (every 3 months) maintenance check beyond the standard monthly check. Without these instructions, facilities may not perform the full maintenance schedule needed to keep the devices in proper working order.

Moderate·FDA·Oct 7, 2026

Aurolab Trust FOCUS PI Hypromellose 0.7% eye drops (a sterile ophthalmic solution) failed to meet sterility standards during manufacturing. Two batches distributed in Virginia are affected. No injuries have been reported.

Moderate·FDA·Oct 7, 2026·Aurolab

The hitch tube weld on certain Kuat Pivot V3 swing-away hitch adapters can crack, causing the cross beam to detach. A detached cross beam can become a road hazard and increase the risk of crashes for other vehicles.

Moderate·NHTSA·Oct 1, 2026·KUAT INNOVATIONS LLC

Love To Dream portable sleep machines contain a lithium-ion battery that can overheat if an incompatible charger is used. This overheating poses a risk of fire or burns.

Moderate·CPSC·Sep 24, 2026

Happiest Baby has distributed extra-small and extra-large sizes of the SNOO Sleep Sack without FDA safety and effectiveness review. These sizes were not cleared through the required regulatory process before being sold.

Moderate·FDA·Sep 23, 2026·Happiest Baby2 products

The VERIQA RT MonteCarlo 3D v3 radiation therapy planning software includes bolus (a material placed on the skin to modify radiation dose) in dose calculations, but does not clearly display that the bolus is accounted for. This may cause treatment staff to accidentally skip the bolus during treatment, leading to radiation being delivered to the wrong tissue depth.

Moderate·FDA·Sep 23, 2026·PTW Freiburg

GE Healthcare's Core Services Hub V8 software, used by hospitals to manage medical imaging workflows, can sometimes link historical imaging data to the wrong patient record during system migrations. If this occurs, a doctor might view images belonging to a different patient, potentially leading to wrong diagnoses or delayed care.

Moderate·FDA·Sep 23, 20266 products

The second-row power seats on certain 2026 Hyundai Ioniq 9 vehicles may fail to detect a person in their path. When the seat moves during automatic fold-and-stow or other powered functions, it could trap a child or adult, causing injury.

Moderate·NHTSA·Sep 11, 2026

Byron White Formulas is recalling three herbal supplements sold as A-L Complex, A-P, and A-FNG, all in 1.0 fl. oz. (30 mL) bottles. The English labels do not list walnuts, which are in the product, so people with a walnut allergy may not know it is there. No injuries have been reported.

Moderate·FDA·Sep 2, 20263 products

A firmware defect in the KidneyVault datalogger may cause it to lose its configuration, resulting in a blank screen and inability to display organ preservation parameters. This affects 1,445 systems distributed across the US. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Paragonix

A screw in the carrying handle of certain Britax child seats (B-Safe Gen 2, B-Safe Gen 2 Flexfit, B-Safe Gen 2 Flexfit Plus, B-Safe 35, B-Safe Ultra, and Endeavours models) may loosen and cause the handle to partially detach. If the handle detaches while a child is being carried, the child could fall.

Moderate·NHTSA·Aug 20, 2026·Britax Child Safety, Inc.

Peter Rabbit Organics Banana & Strawberry fruit puree pouches may contain thin, soft plastic strands from packaging defects. The affected product is a 4-ounce pouch intended for infants and young children aged 6 months and older. About 4,385 pouches from six production dates between January and May 2027 are affected.

Moderate·FDA·Aug 12, 2026·PT Organics

Certain 4 oz Pumpkin Tree Peter Rabbit Organics Banana & Strawberry pouches may release thin plastic strips into the food. The pouches were manufactured between October 25–31, 2025, and distributed only in Oregon. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Cheer Pack

Central Admixture Pharmacy Services Inc. has recalled two patient-specific pediatric Total Parenteral Nutrition (TPN) bags due to incorrect product formulation. The affected bags were compounded with the wrong nutrient mixture. The recall affects only two prescriptions distributed in Georgia with lot numbers 20-1535990-0-1 and 20-1535892-0-1 (expiration July 16, 2026).

Moderate·FDA·Aug 12, 2026·Central Admixture Pharmacy Services

Certain Evenflo Revolve180 Litemax NXT child seats have a miscalibrated level indicator that can result in a child sitting more upright than intended during installation. A child seat that is not reclined as intended increases the risk of injury in a crash.

Moderate·NHTSA·Aug 6, 2026

Medline Industries recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits because the electrical connector at the Neptune humidifier can overheat, causing discoloration, melting, smoke, or burning. When this happens, the device automatically shuts off the heated wire function, which means infants may receive unheated or unconditioned breathing gas that can damage the airway and increase the risk of respiratory complications.

Moderate·FDA·Aug 5, 2026

Nutricia is recalling two meal replacement peptide formulas in 12 oz pouches, Liquid Hope and Nourish, both in Berry Medley flavor and sold under the functional formularies name. The company found that the testing lab used the wrong method, which overstated the vitamin A content, so the products may contain less vitamin A than the label states. No injuries have been reported.

Moderate·FDA·Jul 22, 2026·Nutricia2 products

PT Organics Limited is recalling select 4 oz. Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree pouches sold at Kroger, Meijer, and Target between March and July 2026. An internal packaging defect may have allowed a strand of soft, food-grade plastic to enter some pouches. No injuries have been reported.

Moderate·FDA·Jul 21, 2026·PT Organics

The headrest on certain Evenflo Reo by Revolve360 child seats may shift position during a crash, which could increase the risk of injury to a child. This affects specific color variants including Nantucket, Danvers, Chelsea, Holden, Brookline, and Lenox. No injuries have been reported.

Moderate·NHTSA·Jul 17, 2026

Bard Access Systems is recalling soft tissue biopsy trays (Models 4380 and 4382A) because the lidocaine ampoules included in the kits were manufactured under deficient manufacturing practices. The affected trays are used by healthcare providers to collect tissue samples from patients.

Moderate·FDA·Jul 8, 202614 products

Central Admixture Pharmacy Services issued a recall for one patient-specific Total Parenteral Nutrition (TPN) bag that did not contain copper and famotidine as listed on the label. The bag was prepared for a pediatric patient in Massachusetts. No injuries have been reported.

Moderate·FDA·Jul 1, 2026·Central Admixture Pharmacy Services

GE HealthCare is recalling three Giraffe OmniBed product lines, about 43,300 units in total, used as infant incubators and warmers. Under certain conditions, such as impact during transport, fasteners holding the canopy soffit beneath the control panel can come loose, and a fastener could fall into the patient compartment. In rare cases, the canopy soffit could become loose or detach, which could potentially injure a patient. No injuries have been reported.

Moderate·FDA·Jun 24, 20263 products

Medline Industries distributed multiple surgical convenience kits containing a recalled lot of Mastisol Liquid Adhesive from Ferndale Laboratories. The adhesive tubing may crack when used, making the product unusable during procedures.

Moderate·FDA·Jun 24, 202634 products

Mothers' Milk Bank of Louisiana is recalling specific batches of pasteurized donor human milk (3 oz bottles) because a dark spot was found on the bottom of some containers, which could indicate physical contamination. The affected batches are limited to 32 bottles with expiration date 08/24/2026.

Moderate·FDA·Jun 17, 2026·Mothers' Milk Bank of Louisiana

UC Health Milk Bank's pasteurized donor human milk may contain small plastic particles. The contamination was identified in specific lot codes of both standard (100 mL) and pediatric (200 mL) bottles distributed to medical facilities and consumers in California.

Moderate·FDA·Jun 10, 2026·University of California Health Milk Bank

Tiny Land children's play tents contain fiberglass poles that can shed fibers, causing skin and eye irritation. The company has received eight reports of fiber shedding resulting in irritation. The tents were sold online from November 2025 through March 2026.

Moderate·CPSC·Jun 4, 2026·Tiny Land