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Medline is recalling two suction catheter kit products, with about 142,100 units affected. Some kits may contain an 8 Fr suction catheter instead of the required 14 Fr catheter. Using the smaller catheter could partly or fully block the airway and reduce oxygen. No injuries have been reported.

Serious·FDA·Feb 18, 20262 products

TKS Co-pack Manufacturing is recalling 2 products: Aonic Complete Hers and Aonic Complete His, single-serving 34 ml liquid dietary supplement shots in plastic bottles. The recall was issued because the products may contain coliforms, E. coli, or Pseudomonas aeruginosa. The products were distributed to a customer in Utah, and no injuries have been reported.

Moderate·FDA·Feb 18, 20262 products

McKesson's UDENYCA (pegfilgrastim-cbqv) injection was stored at room temperature instead of in the refrigerator, which may have reduced its effectiveness. This affected 116 cartons from Lot 2199821 with specific serial numbers. The FDA classified this as a Class I recall.

Serious·FDA·Feb 18, 2026·McKesson

Meitheal Pharmaceuticals is recalling Cetrorelix Acetate 0.25 mg injection kits because some contain missing or duplicated needles in the delivery system. This affects lot Q4E0112A with an expiration date of April 30, 2027. The defect could prevent proper injection or cause unsafe handling.

Moderate·FDA·Feb 18, 2026·Meitheal Pharmaceuticals

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 is recalling five premixed IV bags labeled Fagron Sterile Services in Canton, MA: acyclovir, ketamine, thiamine, and two strengths of vancomycin. The company cannot assure the bags are sterile. No injuries have been reported.

Serious·FDA·Feb 18, 20265 products

Asteria Health is recalling 25 sterile pellet products, all sold under the Asteria Health name, for possible metal particles. The products are estradiol and testosterone pellets, including some that also contain anastrozole or triamcinolone acetonide. No injuries have been reported.

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

Some Medtronic MiniMed 780G insulin pumps with software version 6.60 may experience a software timing issue that triggers an error code and stops insulin delivery. This affects specific catalog numbers (MMT-1884, MMT-1886) with certain serial numbers.

Serious·FDA·Feb 11, 2026

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

Boston Scientific is recalling six versions of its AXIOS Stent and Electrocautery-Enhanced Delivery System after reports that the stent did not deploy or expand properly. The most likely result is a longer procedure while the device is swapped for a new one. In rare cases, the stent may need to be removed through a second endoscopic or surgical procedure. No injuries have been reported.

Serious·FDA·Feb 11, 20266 products

Diva Fam Inc's Wildcrafted Sea Moss Gel Superfood may be contaminated with Clostridium botulinum, a bacterium that produces a dangerous toxin. The affected product is sold nationwide in glass jars (16 fl oz) with specific lot codes. No illnesses have been reported so far.

Serious·FDA·Feb 11, 2026·Diva Fam14 products

OptiWize Inc. recalled OptiWize Collagen Plus (320 count bottles) after testing found the manganese level was lower than stated on the label. The company discovered that labeled ingredient quantities did not match the actual amounts in the product.

FDA·Feb 11, 2026·OptiWize

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