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IntegraDose Compounding Services LLC has recalled fentanyl citrate sterile injection (2,250 mcg/50 mL) because the drug may contain less active ingredient than labeled. This lot was distributed nationwide to healthcare facilities.

Moderate·FDA·May 27, 2026·IntegraDose

UCB Biosciences is recalling specific lots of Cimzia (certolizumab pegol) 200 mg prefilled syringes because the manufacturer cannot confirm the product remained sterile during production. This is a precautionary recall; no infections or injuries have been reported so far.

Moderate·FDA·May 27, 2026·UCB Biosciences

Zydus Pharmaceuticals is recalling erythromycin tablets (250 mg) due to the presence of N-Nitroso-Desmethyl-Erythromycin, a nitrosamine impurity, at levels above the FDA's acceptable intake limit. The affected bottles were distributed nationwide. This impurity can potentially increase cancer risk with long-term exposure.

Moderate·FDA·May 27, 20262 products

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

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

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

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

Safecor Health distributed atomoxetine 25 mg capsules that were labeled as 10 mg capsules. This labeling error affects one lot distributed in Texas. The mislabeling could result in patients taking a higher dose than prescribed.

Moderate·FDA·May 27, 2026

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, 20262 products

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, 20262 products

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

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

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

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

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, 202626 products

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

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

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

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

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

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, 20262 products

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

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, 20263 products

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

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

Arrow is recalling four hemodialysis catheter products, 147,367 units in total, because a 16F sheath introducer from a supplier may not split as intended. The defective part was included in affected kits and sets sold worldwide. No injuries have been reported.

Serious·FDA·May 20, 2026·Arrow4 products

GE HealthCare found a potential security weakness in AW Server, a software application used with certain Revolution CT scanners through the Edison Health Link CT Smart Subscription. This recall covers 7 CT scanner products, with 146 units affected in total. No injuries have been reported.

Moderate·FDA·May 20, 20267 products

Medline recalled 11 products, including Namic angiographic and Preceptor manifolds and medical convenience kits that contain Namic manifolds. Medline found particulate matter in the fluid path of the manifolds. No injuries have been reported, and the products were distributed in the US and several other countries.

Serious·FDA·May 20, 202611 products

On-X Life Technologies released and distributed 10 mitral heart valves (Model ONXMC-25/33) before completing all required quality and performance testing. Because testing was incomplete, the company cannot confirm the valves meet all safety and performance specifications. The affected valves were distributed internationally to South Korea.

Moderate·FDA·May 20, 2026·On-X Life Technologies

Windstone Medical Packaging's Custom Convenience Kit (Angio Pack, part numbers AMS6908E and AMS6908F) contains Medline Namic angiographic syringes with a defect: the rotating adapter can unwind during use, causing the syringe to loosen or fully disconnect from the manifold. This disconnection could expose patients to biohazard contamination, blood loss, infection, or air embolism.

Serious·FDA·May 20, 2026