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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

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

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

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

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

Certain rolls of label stock used in Omnicell i.v.Station devices may produce mislabeled syringes during IV medication preparation. The i.v.Station is a pharmacy automation device that compounds IV medications and applies identification labels. Mislabeled syringes could lead to medication identification errors.

Serious·FDA·May 20, 2026·Omnicell

Sun Pharmaceutical is recalling one batch of Aisling doxorubicin hydrochloride liposome injection (a cancer medication) because glass particles were found in some vials during manufacturing. Glass particles in injectable medications can cause local tissue damage, blood vessel blockage, or blood clots if injected into the bloodstream. No patient injuries have been reported so far.

Serious·FDA·May 13, 2026

B. Braun Medical is recalling two lots of Lactated Ringer's Injection (1L, product code E7500) because the solution contains unwanted particles, including cellulose and stearates. If these particles enter a patient's bloodstream during use, they could cause serious complications including blood clots, tissue damage, or organ failure.

Serious·FDA·Apr 28, 2026

Certain Arjo Tenor mobile patient lifts contain actuators with an internal component that may not be strong enough to safely hold the load. In the worst case, this could cause the lifting arm to suddenly drop uncontrolled. This affects 119 units with specific serial numbers manufactured in certain batches.

Serious·FDA·Apr 22, 2026·Arjohuntleigh

Certain versions of the iLet Ace Pump software (1.3.7, 1.4.2, and 1.4.3) have a security flaw that allows someone to bypass the Lock Screen and Limited Access Passcode Screen by pressing icons in the status bar. This could let an unauthorized person make false meal announcements or stop insulin delivery, risking severe low blood sugar.

Serious·FDA·Apr 22, 2026·Beta Bionics

B. Braun is recalling six hemodialysis bloodline tubing sets used during kidney dialysis. Air bubbles can build up in the arterial line because blood gases can stick to the tubing under negative pressure. No injuries have been reported, and the products were distributed across the US and Canada.

Serious·FDA·Apr 22, 20266 products

Certain Omnipod 5 Pods from 49 specific manufacturing lots contain an internal tear in the soft cannula. This defect causes insulin to leak inside the Pod instead of being delivered to your body. In some cases, the Pod may shut down completely and stop delivering insulin, or deliver less insulin than needed.

Serious·FDA·Apr 22, 2026·Insulet

Medline is recalling 19 NAMIC angiographic syringes and Medline convenience kits that contain them. The syringe's rotating adaptor can unwind during use, which may loosen or fully disconnect the syringe from the manifold. No injuries have been reported.

Serious·FDA·Apr 15, 202619 products

Fagron Compounding Services is recalling five premixed IV bags in 0.9% sodium chloride: norepinephrine bitartrate (16 mg and 32 mg per 250 mL) and vancomycin (1 g, 1.25 g and 1.5 g per 250 mL). The bags were made by Fagron Sterile Services in Wichita, Kansas, and sold nationwide, and the company cannot assure they are sterile. A blue break-off part on the administration port could also detach. No injuries have been reported.

Serious·FDA·Apr 15, 2026·Fagron Compounding Services5 products

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance that the product is sterile. This injectable solution is used in medical settings and could pose a risk if contaminated. No injuries have been reported to date.

Serious·FDA·Apr 15, 202614 products

Medtronic is recalling 14 MiniMed insulin pump models, including the Paradigm, 600 series, and BLE 700 series. Changes in pump height relative to the infusion site can cause the pump to deliver too much or too little insulin. No injuries have been reported.

Serious·FDA·Apr 8, 202614 products

Medline is recalling 7 kit products that contain Olympus single-use biopsy valves, totaling about 14,379 kits. Olympus found more complaints of rubber fragments detaching from a slit in the valves. A loose fragment could lodge in a patient's airway and may need to be removed in a procedure. No injuries have been reported.

Serious·FDA·Apr 8, 20267 products

RefleXion Medical's X1 Radiotherapy System has a software defect that can cause radiation treatment to be delivered to the wrong location when certain positioning corrections are made. This may result in radiation doses being delivered 5mm or more away from the intended target, with possible underdosing of 10% to 20%. The issue affects 12 systems running specific software versions.

Serious·FDA·Apr 8, 2026·Reflexion Medical

Philips is recalling four Trilogy ventilator models running Software Version 1.05.15.00, covering 113,717 units in total. In some situations, the Obstruction Alarm does not sound within the time required by applicable standards and may take up to four breaths to trigger. No injuries have been reported.

Serious·FDA·Apr 8, 20264 products

Baxter Healthcare has issued an urgent correction for the Blue Ventilator Adapter Module used with the Volara Respiratory Therapy system in home care settings. Patients or caregivers may not be aware of risks including dangerously low oxygen levels or lung injury from improper device use.

Serious·FDA·Apr 8, 2026

Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.

Serious·FDA·Apr 8, 2026

Abiomed is recalling purge cassettes used in Impella heart pump systems because Generation 1 cassettes have an increased risk of leaking during use. This affects multiple Impella pump models sold globally, with specific batch numbers identified from 2024.

Serious·FDA·Apr 8, 2026

Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.

Serious·FDA·Apr 8, 2026

Medline Industries has recalled specific lots of Puracol and Puracol Plus collagen wound dressings due to elevated endotoxin levels. These contaminants can cause inflammation, tissue irritation, delayed healing, fever, low blood pressure, and in severe cases, septic shock.

Serious·FDA·Apr 1, 2026

Olympus discovered that some Everest Bipolar Cutting Forceps (Model 3006) have welding defects in internal components. These defects can cause the forceps' jaw to break during surgery, potentially requiring additional procedures or intervention.

Serious·FDA·Apr 1, 20267 products

Medtronic has recalled certain MiniMed 780G insulin pumps due to software defects that can cause the pump to deliver too much insulin, too little insulin, or stop delivering insulin entirely. These defects appeared after software updates (versions 6.60, 6.61, and 6.62) and may result in dangerously high or low blood sugar levels. The recall affects over 26,000 pumps with specific serial numbers.

Serious·FDA·Apr 1, 2026

Philips is recalling four Trilogy ventilator models running software version 1.05.15.00: Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal. When non-pneumatic nebulizers are used with these ventilators, the breath volume the patient receives may differ from the amount the device is set to deliver. No injuries have been reported. The recall covers about 113,717 units per model and was distributed nationwide and in many other countries.

Serious·FDA·Apr 1, 20264 products

The Handy Solutions Neck & Shoulders Heating Pad (model 25607) can overheat and cause burns if folded while in use or placed under your body. When folded, the device's safety temperature sensor cannot detect the excessive heat, so it does not shut off. The pad may emit a burning smell before melting or catching fire.

Serious·FDA·Apr 1, 2026

Merit Medical is recalling five products, including CentrosFLO and DuraMax dialysis catheters and 16F dual valved splittable sheath introducers. The sheath introducer may not split as intended, which can cause bleeding, pieces left in the body, procedure delays, or blood clots. No injuries have been reported.

Serious·FDA·Apr 1, 20265 products

Erbe is recalling three models of flexible cryoprobes used in surgery because the probes may rupture or burst during activation. The recall covers about 40,900 units sold nationwide, including Puerto Rico. No injuries have been reported.

Serious·FDA·Apr 1, 2026·Erbe3 products