
FDA•CRITICAL
Reprocessed Electrophysiology and Ultrasound Catheters
Medline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.

Medline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.

Bard recalls dialysis catheters and drainage trays due to deficient lidocaine ampoules.
20 products
Medtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.

Laborie is recalling Solar GI System configurations due to moisture accumulation that may affect pressure measurement performance.

Covidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
2 products
Lupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
Hikma is recalling Gemcitabine Injection due to improper temperature storage.

Zeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.

Siemens is recalling the ARTIS icono ceiling suspension (Model 11328100) because monitor attachment screws may loosen over time.

Windstone Medical recalls DSAEK Pack-RX kits due to contaminated alcohol prep pads.
4 productsRaySearch recalls RayCare 2024A SP1 over beam set delivery note data loss risk.
2 products
Hillrom Volara circuit kits recalled over nebulizer cup leakage causing oxygen drops and ineffective treatment.
4 productsMedela is recalling ENFit Enteral Extension Sets due to incorrect connectors that may cause delivery delays or misconnections.

Accuray is recalling the Xchange Robotic Collimator Changer for the Cyberknife system due to a risk of the collimator falling from its housing.

Siemens recalls ARTIS icono systems over potential loss of movement after detector lift adjustment.
3 products
Accuray is recalling the Cyberknife Xchange Robotic Collimator Changer due to a risk of the component falling from its housing.

Boston Scientific recalls CRE Pro Wireguided balloon dilators over potential sterile pouch breach.
12 products
The IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.

Teleflex is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to potential out-of-specification levels of endotoxins.
2 products
Baxter is recalling the Adapter for Head Positioning due to a risk of the accessory becoming loose and moving during patient positioning.

Spring & Mulberry is recalling Mango Chili and Pecan Date-Sweetened Chocolate bars due to potential Salmonella contamination.
11 products
Accord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.

Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.

Remel is recalling GC Agar Base plates due to a risk of reduced or no recovery of Neisseria gonorrhoeae strains.

Hamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.

Accord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.

Medline recalls convenience kits with Huons Lidocaine ampules over quality issues.
19 products
Medacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.

Medline recalls convenience kits with Swan-Ganz catheters over leak/breakage risk.
9 products
Mentor is recalling a lot of 10cc Luer Lok syringes that were distributed after their expiration date.

High Valley Orchard Chocolate Covered Raisins are recalled due to undeclared peanuts caused by a mis-packaging error.

Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.

Boston Scientific recalls Intera 3000 pump over drug pathway leakage risk.

Medline recalls convenience kits with 10mL polycarbonate syringes over unapproved design changes.
23 products
Abiomed recalls Impella CP introducer kit over thrombus risk.
4 products
Sun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.

Camber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.

Philips is recalling Telemetry Monitor 5500 units due to a potential reset error that prevents connection to the central monitoring system.
IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.

Medline recalls convenience kits with recalled lidocaine and bupivacaine injections due to supplier quality issues.
5 products
GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.

Medtronic recalls Octopus Evolution Tissue Stabilizer over incorrect tubing assembly.
3 products
Surgify Halo drill burr recalled over breakage risk during spinal surgery.
19 products
Stryker is recalling the InZone Detachment System due to premature battery drain that may prevent coil detachment during medical procedures.

Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.

Acumed is recalling various hexalobe screws used in wrist fixation systems due to a risk of the screws breaking during use.
2 products
Amgen recalls Corlanor and Sensipar tablets over foreign substance contamination.
5 products
Zimmer recalls shoulder reamer guides due to breakage risk; 5 complaints reported.
5 productsJoy Gourmet Foods recalls multiple Joy lassi products due to inadequate pasteurization, posing a foodborne illness risk.
14 products