Hawaii recalls

Sold nationwide. ANI Pharmaceuticals is recalling estradiol gel (0.1%, 0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled. This could mean patients receive less medication than prescribed. The recall affects carton lot M251109, which expires in November 2027.

Moderate·FDA·May 27, 2026·ANI Pharmaceuticals

Sold nationwide. Gas-X Simethicone 125 mg softgels distributed by Haleon are being recalled because the carton labeling does not list all inactive ingredients. This affects three specific lot codes (KB5Y, MP4B, and SS4F) distributed nationwide.

Moderate·FDA·May 27, 2026·Haleon

Sold nationwide. Lupin Pharmaceuticals is recalling certain batches of Liraglutide Injection (a diabetes and weight-loss medication) because white thread-like particles have been found inside the cartridges. The affected pens are distributed nationwide. No injuries have been reported.

Moderate·FDA·May 27, 2026·Lupin

Sold nationwide. Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots are 656412 (expiring 08/31/2026) and 659646 (expiring 03/31/2027). This is a prescription medication used in cancer treatment.

Moderate·FDA·May 27, 2026·Sagent Pharmaceuticals

Sold nationwide. Primidone tablets distributed by American Health Packaging were found to contain trace amounts of Acemetacin, a different active pharmaceutical ingredient, due to cross-contamination during manufacturing. The affected lot (1027583, expiring 09/30/2027) contains approximately 63,500 tablets distributed nationwide. No injuries have been reported.

Moderate·FDA·May 27, 2026·Amerisource2 products

Sold nationwide. Golden State Medical Supply is recalling Primidone 50 mg tablets because the active ingredient was contaminated with trace amounts of Acemetacin, a different medication. This contamination occurred during manufacturing. The affected bottles are identified by specific lot numbers with expiration dates in 2028.

Moderate·FDA·May 27, 2026·Golden State Medical Supply2 products

Sold nationwide. Lannett Company's Primidone Tablets 250mg were contaminated during manufacturing with trace amounts of Acemetacin, a different active pharmaceutical ingredient. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

Moderate·FDA·May 27, 2026·Lannett

Sold nationwide. Insulet found a manufacturing issue in certain lots of Omnipod 5, Omnipod DASH, and Omnipod Eros pods that could cause insulin to leak instead of being fully delivered into the body. The leak occurs when a small tear develops in the tubing just above the skin. In some cases, users may not notice the problem, which can lead to high blood sugar levels and, in severe cases, diabetic ketoacidosis.

Serious·FDA·May 26, 2026·Omnipod

Sold nationwide. Dexcom discovered that two lots of its G7 continuous glucose monitoring sensors—originally designated as scrap and scheduled for destruction—were stolen before being destroyed and sold by an unauthorized third party. One lot has an increased risk of skin infection due to improper sterilization; the other has an increased risk of sensor failure.

Moderate·FDA·May 26, 2026·Dexcom G7

Sold nationwide. Mogo Moringa LLC is voluntarily recalling two specific lots of Mogo Moringa Oleifera Capsules due to a possible Salmonella contamination concern. The affected lots are Lot 15525AA (expires 06/2027) and Lot 00926AA (expires 01/2028). No Salmonella was detected in the company's own testing, but the recall is being issued as a precaution while the FDA continues its review.

Serious·FDA·May 25, 2026·Mogo

Sold nationwide. The LED lights inside these decorative spheres can overheat and catch fire. The company has received nine reports of sparking or overheating, though no injuries have been reported so far.

Serious·CPSC·May 21, 2026·Bethlehem Lights

Sold nationwide. These LED shot glasses contain button cell batteries in an easily accessible compartment. Children can remove and swallow the batteries, which can cause serious internal burns and death. The glasses also lack required safety warnings.

Serious·CPSC·May 21, 2026·ABC Trading

Sold nationwide. PandaEar portable hook-on chairs have a safety defect: the crotch restraints can be removed without tools, allowing infants to fall through an opening. This violates the mandatory safety standard for these products and poses a serious injury or death risk.

Serious·CPSC·May 21, 2026·PandaEar

Sold nationwide. Lil Pick Up's Sierra 125U youth ATVs (sold under the brand name "Rider 9") do not meet federal safety standards. The ATVs have faulty suspension, a reverse light that doesn't work, brakes that don't hold properly, and surfaces near the footwell that can become hot enough to cause severe burns.

Serious·CPSC·May 21, 2026·Lil Pick Up

Sold nationwide. ORB Toys' Funkee squeeze toys may contain asbestos-like fibers in the sand filling. If the toy ruptures or leaks, inhaling this dust could cause serious health problems. The recalled toys have date code 3102491A and were sold at Walmart and Ollie's Bargain Outlet between February 2025 and April 2026.

Serious·CPSC·May 21, 2026·ORB Toys

Sold nationwide. HomeProGym-branded resistance bands can forcefully separate from the handle during use, creating a risk of serious impact injury. The recall affects only purple 60-pound and gray 70-pound bands sold in various sets and bundles between December 2025 and April 2026. No injuries have been reported so far.

Serious·CPSC·May 21, 2026·HomeProGym

Sold nationwide. ABC Trading toy headbands and electronic pet cages contain button cell batteries in compartments that children can easily open. Swallowing these batteries can cause serious internal burns and death.

Serious·CPSC·May 21, 2026·ABC Trading

Sold nationwide. A software issue in the A810 Clinician Programmer App can cause infusion steps to display out of order in rare cases. When this happens, the SynchroMed Flex infusion pump may not deliver medication at the intended time, or not deliver it at all. The issue affects specific clinician tablet models running software versions 1.x and 2.x.

Moderate·FDA·May 20, 2026·Medtronic

Sold nationwide. MicroVention LVIS stent-assist devices may have incorrect dimensions or configuration due to a manufacturing mix-up. Devices that are too large can damage blood vessel walls; devices that are too small may not expand properly or could cause blood clots and stroke.

Serious·FDA·May 20, 2026·Microvention

Sold nationwide. Stryker is recalling 26 reprocessed electrophysiology catheters because their sterile packaging seals may be incomplete. The products were distributed across the US and to Israel and Canada. No injuries have been reported.

Moderate·FDA·May 20, 2026·Stryker26 products

Sold nationwide. Integra LifeSciences recalled Codman CerebroFlo EVD Catheters (Product ID 37.550.501, Lot 45322) because testing found endotoxin levels that exceeded safety standards. Endotoxins are bacterial fragments that can trigger harmful immune responses in patients. The affected catheters are used to drain fluid from the brain in hospital settings.

Moderate·FDA·May 20, 2026·Integra LifeSciences

Sold nationwide. Edwards Lifesciences has updated the labeling for its EVOQUE tricuspid delivery system to include a warning about potential loss of device functionality during valve replacement procedures. This is a labeling change to help clinicians recognize and respond to compromised system performance. No injuries have been reported.

Moderate·FDA·May 20, 2026·Edwards Lifesciences

Sold nationwide. Lot FD1265 of the ZYMUTEST HIA IgG diagnostic kit was shipped with an outdated instruction flyer that contained incorrect values for the positive control. This could lead to misinterpretation of test results if users rely on the wrong reference values.

Moderate·FDA·May 20, 2026·Aniara Diagnostica

Sold nationwide. Bolts and plastic parts on the Cable Hose Carriers that attach cable hoses to the monitor ceiling suspension may loosen or break over time when the monitor is moved or rotated. This affects multiple Azurion 3, 5, and 7 model variants.

Moderate·FDA·May 20, 2026·Philips

Sold nationwide. Certain lots of the Quidel QuickVue Dipstick Strep A Test may return false positive results, meaning the test could indicate a strep infection when one is not actually present. This could lead to unnecessary antibiotic treatment. The recall affects specific lot numbers distributed across the US.

Moderate·FDA·May 20, 2026·Quidel

Sold nationwide. Hologic is recalling 2 mammography system product lines, covering about 19,140 units nationwide. The company received complaints that internal bolts in these systems can become loose, missing, or broken over time. No injuries have been reported.

Moderate·FDA·May 20, 2026·Hologic2 products

Sold nationwide. Stryker Corporation recalled a limited lot of FluidSmart Urology Tube Sets (REF LL0006) used with fluid management systems in surgical procedures. Some units in this lot did not meet manufacturing standards. No injuries have been reported.

Moderate·FDA·May 20, 2026·Stryker

Sold nationwide. Dexcom is recalling three software products for the G7 and ONE+ continuous glucose monitoring apps on iOS and watchOS. A software defect can delay glucose readings and trend arrows while the app runs in the background, and old readings may then appear in sequence when the app is reopened. No injuries have been reported.

Moderate·FDA·May 20, 2026·Dexcom3 products

Sold nationwide. Diowave 250W infrared laser systems used for temporary muscle and joint pain relief are operating at a maximum power output of 70W, which exceeds the FDA-cleared limit of 60W. A software update is required to correct the power output to the approved level.

Moderate·FDA·May 20, 2026·Technological Medical Advancements

Sold nationwide. A subset of Jolife LUCAS 2, LUCAS 3, and LUCAS 3.1 chest compression devices did not have complete service documentation on file. The service records lack paperwork that would verify these devices passed their required checks. This affects 153 devices across 20 U.S. states.

Moderate·FDA·May 20, 2026·Jolife