FDA medical device recalls

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG DR. (Model SL-2010M2096A) due to a potential risk of small air bubbles accumulating in the arterial line during hemodialysis treatment. This happens when blood gases stick to the tubing under negative pressure, which could affect treatment safety. The recall affects units manufactured on or after June 9, 2025.

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.

Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.

Brahms GmbH is recalling certain lots of the B.R.A.H.M.S PlGF Plus KRYPTOR, a blood test used to assess preeclampsia risk during pregnancy. Quality control checks at the lowest level (QC Level 1) may show out-of-range values that could mask an underlying problem if not performed correctly. This could lead to falsely high test results that overestimate preeclampsia risk.

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Certain Spacelabs Healthcare Model 91496 multi-parameter cardiac monitors have a circuit board defect. When the device is in Auto mode, the cardiac output measurement may start too early, causing errors that prevent proper readings or exclude readings that should be included. This could lead to inaccurate patient information and delayed medical decisions.

Cook Medical's Wayne Pneumothorax Tray kits in certain lots were labeled with expiration dates that go beyond when the devices are actually safe to use. This affects 318 units distributed worldwide. No injuries have been reported.

Cook Medical's Wayne Pneumothorax Set (certain lot numbers) was labeled with expiration dates that go beyond when the device is actually safe to use. This affects 104 units distributed worldwide. No injuries have been reported.

Cook Medical's Thal-Quick Chest Tube Tray (model C-TQTSY-3200) from two affected lots was labeled with expiration dates longer than the actual shelf life of the product. This means the sterile chest tube trays may not remain safe to use after their true expiration date has passed.

Cook Medical Spectrum Central Venous Trays from certain lots were labeled with expiration dates longer than the products' actual shelf life. This means some trays marked as safe to use may have degraded beyond their true usable period. Approximately 2,348 units are affected across multiple lot numbers.

Cook Medical Spectrum Central Venous Catheter Sets in certain lots were labeled with expiration dates that go beyond their actual shelf life. This means some catheters may have degraded beyond their labeled date of use. No injuries have been reported.

Cook Medical's NCompass Nitinol Stone Extractor devices in certain lots were labeled with expiration dates that go beyond the actual shelf life of the product. This affects 70 units distributed worldwide. No injuries have been reported.

Cook Medical multipurpose drainage catheters from two specific lots were labeled with expiration dates that go beyond their actual safe shelf life. This means catheters could be used after they are no longer guaranteed to be sterile or safe. The affected catheters were distributed worldwide, and 20 units are involved.

Cook Incorporated discovered that certain lots of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set were labeled with expiration dates longer than the actual shelf life of the product. This means some units may have been used past their true expiration date, potentially affecting sterility and safety.

Cook Medical's Strange Bile Duct Stone Exploration Set (model C-CSRC-7.5D-40-STRANGE) in five specific lot numbers has been labeled with expiration dates that are longer than the device's actual shelf life. This means the device may degrade or fail before the printed date suggests it should.

Cook Medical issued a recall of certain Spectrum Central Venous Catheter Tray units because the labels show expiration dates that are longer than the actual shelf life of the product. This means some trays labeled as usable may have actually expired. No injuries have been reported.

Cook Medical's Staged Extubation Set (Part Number C-CAE-14.0-83-EXTU, Lot 16010654) was labeled with expiration dates that go beyond when the device is actually safe to use. About 95 units were distributed worldwide. No injuries have been reported.

Cook Medical's Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set in certain lots has been labeled with expiration dates that extend beyond the actual shelf life of the product. This affects 484 units distributed worldwide. No injuries have been reported.

Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray was labeled with expiration dates that are longer than the actual shelf life of the product. This affects specific lot numbers distributed worldwide. No injuries have been reported.

Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set from certain lots was labeled with expiration dates longer than the actual shelf life of the device. This means some units may have degraded before their printed expiration date, potentially affecting performance when used.

Cook Medical arterial pressure monitoring trays in three specific lots were labeled with expiration dates that go beyond their actual shelf life. This means the devices may not perform as expected if used after their true expiration. Twenty units were affected and distributed worldwide.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Cook Medical's Approach CTO-12 Micro Wire Guide devices in three affected lots have expiration dates printed on the packaging that go beyond when the devices actually expire. This could lead to use of degraded or ineffective devices. No injuries have been reported.

Cook Medical's Approach CTO-6 Micro Wire Guide (Part CMW-14-190-6G, Lot 15288005) was labeled with expiration dates that go beyond when the device actually expires. This means the device may no longer be safe or effective to use after the true expiration date, even though the label says it is still good.

Molded Products Inc. is recalling the MPC-130 See Luer Cap Set used in medical IV administration. The threaded sleeve can fail to engage properly, causing the cap to become detached during use. This affects 26,900 units distributed across Tennessee, Texas, Nevada, Illinois, and Florida.

Two units of XTANT Medical Xpress Pedicle Screw System (Part Number X073-6555-DL, Lot 4375-01) were mislabeled with an incorrect part number. The label indicates a shorter screw length than what the device actually is, which could cause confusion during surgical use.

Beckman Coulter identified a manufacturing defect in certain MicroScan Neg MIC 3J antibiotic susceptibility test panels (Catalog C54814, Lot 2025-08-23). Some panels are missing a drug in one well and contain double the amount of antibiotics in others, which could produce inaccurate test results. No injuries have been reported.

Tornier, Inc. recalled three shoulder implant parts that were incorrectly labeled as compatible with the Tornier HRS Max system. These parts actually work only with the older Tornier HRS system and will not fit properly in HRS Max procedures. A total of 233 units with specific lot numbers were distributed nationwide.

Medline has recalled certain shoulder arthroscopy and extremity medical convenience kits because the syringe adapter may unwind during use. This could cause the syringe to loosen or disconnect from the manifold, potentially disrupting a medical procedure. No injuries have been reported.