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American Health Packaging is recalling certain oxycodone hydrochloride 5 mg tablets because the blister card seals are defective or missing. This allows tablets to fall out of their compartments. The recall affects 31,676 packages distributed nationwide with specific lot numbers and expiration dates.

Moderate·FDA·Feb 18, 2026

Fresenius Kabi Compounding has recalled five specific lots of ketamine HCl injection (10 mg per mL) distributed nationwide because the manufacturer cannot confirm the product remains sterile. The affected lots were produced between February and April 2026.

Moderate·FDA·Feb 18, 20265 products

Asteria Health is recalling estradiol hormone pellets (10 mg) because they may contain metal particles. The affected pellets were distributed nationwide. No injuries have been reported so far.

Moderate·FDA·Feb 18, 2026·Asteria Health25 products

Unichem Pharmaceuticals distributed 60,000 tablets of Doxazosin 4 mg with incorrect imprinting on the tablets themselves. This labeling error could cause confusion about the medication's identity and strength. The affected lot is GDSH25006, which expires in August 2027.

Moderate·FDA·Feb 18, 2026·Unichem Pharmaceuticals

Pro Numb is recalling two tattoo numbing sprays because they were made in ways that did not meet FDA manufacturing standards. The recall covers Pro Numb Tattoo Numbing Spray 5% Lidocaine and Pro Numb Tattoo Numbing Spray For Sensitive Skin 4% Lidocaine, sold nationwide in the USA. No injuries have been reported.

Moderate·FDA·Feb 18, 2026·Pro Numb2 products

Etac is recalling four Molift mobile patient hoist and sling bar products, covering 255 affected units. A customer reported that the bolt mounting the lifting bar broke during assembly and load testing. The company found that material deformation between the lifting bar and the device arm can limit joint mobility and stop the equipment from working properly. No injuries have been reported.

Moderate·FDA·Feb 11, 2026·Etac4 products

Maquet Cardiopulmonary identified a durability problem with the connecting cable on its Venous Bubble Sensor (Model 701055720). Excessive bending of the cable can damage the sensor or loosen the connection, causing error messages on the connected medical device—either temporarily when the cable moves or permanently if the connection fails.

Moderate·FDA·Feb 11, 2026

FUJIFILM Healthcare Americas has recalled certain FDR Visionary Suite X-ray systems (Model CH-200) because internal electrical contacts can become welded together. This may allow power to continue flowing to the system even after it is turned off, which could cause the circuit to overheat, damage nearby parts, and create smoke.

Moderate·FDA·Feb 11, 2026

Wilson-Cook Medical is recalling certain nasal jejunal feeding tubes (model NJFT-10) because some units were shipped without the nasal transfer tube component, making them incomplete and unusable. The recall affects 60 units distributed in Australia.

Moderate·FDA·Feb 11, 2026

Olympus is recalling 30 sphincterotome devices, which are used with an endoscope during medical procedures. Some units were not thermoformed as required and could deform, losing performance. No injuries have been reported.

Moderate·FDA·Feb 11, 202630 products

Changchun Wancheng is recalling 11 product listings of home test strips and diagnostic tests, including urinary tract infection, ovulation, menopause, fertility and Vivoo tests. The devices were distributed in the U.S. before FDA clearance (510(k)), and they may give false or inaccurate results to users, which could lead to inappropriate medical treatment. The recall was distributed nationwide, with confirmed distribution in Texas, Georgia and California.

Moderate·FDA·Feb 11, 2026·Changchun Wancheng11 products

Vortex Surgical is recalling 13 ophthalmic surgical products, including laser probes, forceps, cannulas, and related kits, because the Tyvek pouch seals may have voids. A damaged seal can compromise the sterile barrier and allow bioburden contamination, which could lead to infection. No injuries have been reported.

Moderate·FDA·Feb 11, 2026·Vortex Surgical13 products

Focalyx Fusion, a software device used to guide prostate biopsies and diagnostic procedures, may not work properly on Windows 10 operating systems. This malfunction could harm patients during biopsy or delay needed treatment. The manufacturer recommends stopping use of affected software versions until the device is confirmed to work with Windows 11.

Moderate·FDA·Feb 11, 2026·Focalyx

Siemens is recalling three brain imaging software applications installed on certain CT systems because they have not received FDA 510(k) clearance. The recall covers 4 CT system models, with 97 units affected, distributed in the US and Canada, Costa Rica, India, and Israel. No injuries have been reported.

Moderate·FDA·Feb 11, 20264 products

A specific lot of Tornier surgical screws (catalog DWJ318, lot AZ4824290) is labeled as 5.0mm×18mm but actually contains 5.0mm×14mm screws. If the wrong size is used without detection during surgery, it could increase the risk of mechanical failure and the need for revision surgery.

Moderate·FDA·Feb 11, 2026·Tornier

A software error in the Beckman Coulter CellMek SPS Sample Preparation System (model C44603, software version 2.3.90.0) causes samples to be dispensed incorrectly, potentially damaging the instrument and losing 60–100 microliters of sample fluid. This could lead to inaccurate test results and incorrect patient care decisions.

Moderate·FDA·Feb 11, 2026

Encore Medical is recalling two EMPOWR surgical device products, 68 units in total, because some packages may contain the wrong acetabular system or may have a packaging discrepancy. One acetabular system package was found to contain a different device, and other acetabular system and knee insert devices may be affected. The problem could delay surgery while devices are exchanged or lead to a revision surgery. No injuries have been reported.

Moderate·FDA·Feb 11, 2026·Encore Medical2 products

A software error allowed robotic instrument arms with bent or misaligned parts to remain in use during surgery. These parts can wear out and potentially fail during a procedure. Intuitive Surgical identified specific serial numbers of affected systems.

Moderate·FDA·Feb 11, 2026

Vantive is recalling eight Prismaflex and Oxiris dialysis set products distributed nationwide. The deaeration chamber on these sets may become dislodged from the Prismaflex Control Unit. No injuries have been reported.

Moderate·FDA·Feb 11, 2026·Vantive8 products

Olympus Corporation is recalling certain single-use electrosurgical knives (model KD-640L) used during endoscopic surgery. The cutting knife can overheat, burn, and break during use, which could affect the surgery. No injuries have been reported.

Moderate·FDA·Feb 11, 20262 products

Beckman Coulter has recalled specific lots of COULTER DxH Diluent and COULTER DxH ECO Diluent used in blood cell analysis systems. These affected lots can produce inaccurate platelet count readings during daily quality checks, which may lead to unreliable test results.

Moderate·FDA·Feb 11, 2026

Sun Pharmaceutical is recalling one lot of Diclofenac Sodium Topical Gel, 3% (Lot #AD92721, expiring 3/31/2027) because the gel's thickness is slightly lower than required specifications. The product was distributed nationwide and is sold by prescription only.

Moderate·FDA·Feb 11, 2026

Granules Pharmaceuticals is recalling certain bottles of trazodone 50 mg because some bottles may contain foreign tablets or capsules mixed in. This affects 71,424 bottles with batch number 6160008A and an expiration date of 12/31/2026. No injuries have been reported.

Moderate·FDA·Feb 11, 2026·Granules

Unichem Pharmaceuticals is recalling one lot of bisoprolol fumarate and hydrochlorothiazide tablets (2.5 mg/6.25 mg) because they contain higher-than-allowed levels of N-Nitroso Bisoprolol, a potentially harmful impurity. The affected lot was manufactured in India and distributed nationwide.

Moderate·FDA·Feb 11, 2026·Unichem Pharmaceuticals

Miach Orthopaedics BEAR Implant Model 1000 units have an incorrect expiration date printed on the label that extends beyond the product's actual shelf life. Because the expiration date is wrong, the UDI (Unique Device Identifier) is also incorrect. This affects 284 units distributed nationwide.

Moderate·FDA·Feb 4, 2026·Miach Orthopaedics

LSL Healthcare's Central Line Dressing Kit (Model 2519CP) contains BD ChloraPrep Triple Swabsticks with damaged packaging—some applicator seals are open. An open seal can allow the sterile applicator to become contaminated before use. This affects about 1,400 kits distributed in Idaho with lot number 5G3119 and expiration date 7/31/26.

Moderate·FDA·Feb 4, 2026·LSL Healthcare

LimFlow Vector vascular devices (Model VT-US-23, Lot 82321838) were distributed with an incorrect expiration date printed on the packaging. This affects 33 units distributed across multiple U.S. states. An incorrect expiration date could lead to use of a device beyond its safe lifespan.

Moderate·FDA·Feb 4, 2026·LimFlow

Some BD Alaris Pump Module 8100 infusion pumps have a software date/time issue related to daylight saving time that may prevent them from connecting to hospital networks. This affects only the network connectivity function; the pump's ability to deliver medication is not impacted. The issue involves 189 devices distributed in Arizona, Indiana, Ohio, and Virginia.

Moderate·FDA·Feb 4, 2026

Philips is recalling 13 MR imaging system products because exported MR Elastography stiffness maps may show incorrect stiffness values when viewed in a PACS image viewer. No injuries have been reported.

Moderate·FDA·Feb 4, 202613 products

The screen on Zimmer A.T.S. 5000TS Tourniquet Systems may freeze or stop responding when used in certain non-English language settings. This can delay surgery while staff locate an alternate device. The issue affects systems running software version v2.04 or earlier.

Moderate·FDA·Feb 4, 20262 products