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Summa Therapeutics is recalling certain Finesse BTK Multicath injectable angioplasty balloon catheters because the balloon may not meet burst strength specifications. This could cause the balloon to rupture unexpectedly during a medical procedure. The recall affects 22 units distributed in New Jersey and Florida.

Moderate·FDA·Apr 8, 2026·Summa Therapeutics

Synthes is recalling two bone screw taps, the VOLT Locking Screw Tap and the VOLT Cortex Screw Tap, because two production lots were swapped, so the taps may have an incorrect thread. The recall covers 110 units across 21 states, and no injuries have been reported.

Moderate·FDA·Apr 8, 2026·Synthes2 products

Intuitive Surgical is recalling two da Vinci S and Si reusable surgical instruments, totaling 8,247 units, after the company received complaints of frayed or broken pitch cables. The products were distributed across the U.S. and in many other countries. No injuries have been reported.

Moderate·FDA·Apr 8, 20262 products

Intuitive Surgical is recalling four reusable instrument models used with da Vinci S and Si robotic surgical systems. The company received increased complaints of broken or frayed grip cables. No injuries have been reported, and the instruments were distributed in the U.S. and in many other countries.

Moderate·FDA·Apr 8, 20264 products

Olympus is recalling some SOLTIVE laser systems because a 24V power supply module may fail and make the system inoperable. The defect may also cause smoke or a burning smell, which is designed to stay inside the laser console and extinguish itself. No injuries have been reported. The recall covers 2 products, with 440 units affected, distributed in the US and several other countries.

Moderate·FDA·Apr 8, 20262 products

Medline Industries identified a potential breach in the sterile pouch packaging of one lot of Sterile Radiology Procedure Kits (Model DYNDH1491B). This breach may allow the kit to lose its sterile condition. No injuries have been reported.

Moderate·FDA·Apr 8, 2026

Philips Vue Motion V12 cardiac imaging software (Product Number 1017979, software versions 12.2.0 through 12.2.8.500) may display image frames out of sequence during dynamic cine runs. This could cause medical staff to review cardiac images in the wrong order, potentially affecting diagnosis.

Moderate·FDA·Apr 8, 2026

Medline recalled two products: ENFit G-tube connectors and kits that contain them. The connectors were not made to required dimensions, so they may not seal properly with ENFit-style devices and can leak. No injuries have been reported.

Moderate·FDA·Apr 8, 20262 products

Ultradent Products is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk because the cups may crumble or break apart during use. This could delay dental treatment. The affected product has lot number 529983 and expiration date of September 2, 2031.

Moderate·FDA·Apr 8, 2026·Ultradent Products

The surgical light assembly in Stryker CHROMOPHARE Softlit Ring systems may not adequately support the weight of the ceiling cover. This could potentially cause the cover to fall. No injuries have been reported.

Moderate·FDA·Apr 8, 2026

Mentor is recalling 7 product lines of breast tissue expanders, including CPX 4 US and Artoura models. The recall notice says the needle tip may be dull or blunt, which could make it hard to advance or cause it to break. No injuries have been reported. The notice refers to infusion sets, while the listed products are tissue expanders, so check the notice for details.

Moderate·FDA·Apr 8, 2026·Mentor7 products

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

Moderate·FDA·Apr 8, 202622 products

BD Kiestra ReadA lab automation systems (Catalog No. 446948) may occasionally lose remote connectivity after a system reboot, which could temporarily delay plate retrieval from the incubator. The issue is intermittent and does not affect test results, assay performance, or sample integrity. This affects 82 units distributed across the United States and internationally.

Moderate·FDA·Apr 8, 2026·BD Kiestra

Siemens has recalled certain lots of its Atellica CH A1c_E hemoglobin test kit because when used with another reagent (RCRP) on the same analyzer, the A1c test may give lower-than-accurate results. Lower results could delay diabetes diagnosis or lead to inadequate treatment. This issue does not affect labs using separate analyzers for each test.

Moderate·FDA·Apr 8, 2026

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

ReCor Medical distributed one Paradise ultrasound renal denervation catheter (Model PRDS-068-02, Lot M4907) that did not meet manufacturing standards and was supposed to be destroyed. The device was distributed in nine U.S. states. No injuries have been reported.

Moderate·FDA·Apr 8, 2026·ReCor Medical2 products

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

Imu-Tek Animal Health is recalling two products: Imu-Tek Colostrum-5 120-capsule bottles and Imu-Tek Colostrum-5 powder bottles. The company says the product may not have been fully processed. No injuries have been reported.

Moderate·FDA·Apr 8, 2026·Imu-Tek2 products

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

Appco Pharma LLC is recalling prazosin hydrochloride 1mg capsules (100-count bottles) because they may contain higher-than-acceptable levels of a nitrosamine impurity. This impurity was detected during manufacturing quality checks. The recall affects specific lot numbers distributed nationwide.

Moderate·FDA·Apr 8, 2026·Appco Pharma3 products

K.C. Pharmaceuticals is recalling eight sterile eye drop products because the company cannot confirm they are sterile. The drops were sold under store and pharmacy brands including Best Choice, Walgreens, GERI CARE, LEADER, Good Sense, Industrial Eye Relief and Rugby. No injuries have been reported.

Moderate·FDA·Apr 8, 20268 products

Amneal Pharmaceuticals is recalling specific lots of tramadol 50 mg tablets because they contain higher-than-allowed levels of a chemical impurity called N-nitroso-desmethyl-tramadol (NDSRI). The impurity was discovered during stability testing of tablets nearing the end of their shelf life. No injuries have been reported.

Moderate·FDA·Apr 8, 2026

Alembic Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.07% because the medication failed purity and degradation tests during stability testing at 20 months. The affected eye drops may contain higher-than-acceptable impurity levels, which could affect safety and effectiveness.

Moderate·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

The labeling on BD Alaris System with Guardrails Suite MX does not specify which version of Transport Layer Security (TLS) must be enabled on hospital networks for secure Wi-Fi communication with Point-of-Care Units. This could create confusion during setup and potentially leave devices with inadequate security settings.

Moderate·FDA·Apr 1, 2026

Olympus is recalling seven models of bipolar and PK/PKS cutting forceps, 3,788 units in total, used in medical procedures. The supplier did not adequately validate a welding process for components, and defective welds could cause the forceps' jaw to break during clinical use. No injuries have been reported.

Moderate·FDA·Apr 1, 20267 products

Tandem Diabetes Care insulin pumps distributed in the Czech Republic and Slovakia have translation errors in their Czech language user guide. The most serious error tells users to verify the infusion set is connected to the body when it should say the opposite—that it should NOT be connected. Following these incorrect instructions could cause unintended insulin delivery and dangerously low blood sugar.

Moderate·FDA·Apr 1, 2026