Medical device recalls

Certain Penner Pacific Bathing Spa models do not have a unique device identifier (UDI) as required by federal regulations. This affects 643 units with specific serial numbers. No injuries have been reported.

Penner Patient Care is recalling certain Penner Pacific Bathing Spa models because they do not have the required unique device identifier marked on them. This identifier helps track and manage the device if problems arise. No injuries have been reported.

Raz Design mobile shower commode chairs may have improperly engaged rear seat brackets due to a vendor modification. This could cause the seat to become loose or detach during use. The recall affects multiple Raz models nationwide.

A safety feature in the IBA PROTEUS 235 proton therapy system can become disabled, preventing automatic beam shutdown if an external gating device loses signal. This affects only 4 specific units worldwide and may result in incorrect radiation delivery during treatment.

Becton Dickinson discovered that some Luer Slip syringes were accidentally mixed into batches of 10mL Luer-Lok syringes during packaging. This affects product Catalog Number 301029, Lot 5268614, distributed in California and Texas. No injuries have been reported.

Medline's Unna-Z Stretch Zinc Paste Bandage has incomplete ingredient information on the label. The product contains castor oil and calamine, but these ingredients were not listed on the packaging. This labeling error affects batches distributed in Illinois.

Olympus has identified a mis-wired component in certain ShockPulse-SE Lithotripsy System generators (model SPL-G) that can cause electrical noise in the ultrasonic circuit. This noise may reduce the system's reliability and delay treatment. The recall affects 55 units distributed internationally.

Advanced Bionics is recalling certain Sky CI M90 Sound Processors because the label on the package does not match the product inside. Two units with specific serial numbers (249596 and 249603) are affected. No injuries have been reported.

Vascutek vascular repair grafts (Gelsoft Plus and Gelweave models) were labeled with expiration dates that are too long. The shelf life was incorrectly calculated from the packaging date instead of the gel treatment date. This means some devices may expire sooner than the label states.

Diagnostica Stago's STA Liatest Free Protein S testing kits (model REF 00516) may produce inaccurate results, potentially underestimating free protein S levels in normal patient samples. This affects specific lot numbers distributed nationwide and internationally. No injuries have been reported.

Esaote has identified a weakness in the probe body on a specific production batch that may cause liquid to leak from the cable connection area. Five units with specific serial numbers were distributed in North Carolina and Texas.

Olympus has recalled its Single Use Biopsy Valve (model MAJ-1218) used during endoscopy procedures. Small rubber fragments may detach from the valve during use, potentially entering the patient's body. No injuries have been reported, but the risk prompted this recall of about 25,500 affected valves.

Olympus has recalled the MAJ-210 single-use biopsy valve (a device that attaches to endoscopes to prevent fluid backflow) because rubber fragments may detach during use. The recall affects all lot numbers of this product sold nationwide. No injuries have been reported to date.

Datascope Corp. has identified that the battery runtime and cycle specifications in the instruction manual for the CS300 IABP (intra-aortic balloon pump) device need to be corrected. The device itself is safe to use, but the written specifications may not accurately reflect actual battery performance.

Datascope Corp. identified that the battery runtime and cycle specifications in the instruction manual for the CS100 IABP (intra-aortic balloon pump) device are incorrect and need to be updated. The device itself is not defective, but users may rely on outdated battery information.

Aesculap Inc. is recalling certain MINOP Trocar 150mm surgical instruments (model FF399R) because the shaft may be longer than intended. This surgical tool is used during minimally invasive procedures. No injuries have been reported so far.

Siemens Healthcare Diagnostics recalled its Atellica CH Urine Albumin test kits because they may report falsely low results for high-protein urine samples. If a sample contains more than 40.0 mg/dL of albumin, the test may incorrectly show a value between 6.2 and 40.0 mg/dL instead. This affects all lot numbers of Material Number 11537225 distributed worldwide.

B. Braun Medical Inc. recalled certain winged infusion sets used to expand tissue expanders because the needle tips may be dull, blunt, or break during use. This could make it difficult to insert the needle or cause it to break inside the body. No injuries have been reported.

B. Braun Medical Inc is recalling certain 21-gauge winged infusion needles used to expand tissue expanders. The needle tips may be dull, blunt, or break during use, which could make the device difficult or impossible to use properly.

B. Braun's 21G winged injection needles used for tissue expander procedures may have dull, blunt, or broken needle tips. This can make the needle difficult to advance during use. The issue affects specific lot numbers with expiration dates through September 2032.

Staar Surgical EVO+ Visian Toric Implantable Collamer Lenses (Model VTICM5) were labeled as 12.1 mm but are actually 12.6 mm in length. The larger size can cause the lens to sit too high in the eye, potentially reducing eye drainage and increasing eye pressure, which may lead to discomfort, vision problems, or the need for lens removal.

The Olympus ShockPulse-SE Lithotripsy System generator (model SPL-G) may fail to recognize its transducer and remain in a blinking waiting state. This can happen if the transducer plug or generator receptacle becomes damaged. The device is used in medical settings to break up kidney stones and similar calculi.

The Olympus ShockPulse-SE Lithotripsy System, used to break up kidney stones and similar calculi, may experience problems where the generator remains in a blinking phase and fails to recognize the transducer. This can happen if the transducer plug or generator receptacle becomes damaged. No injuries have been reported.

Olympus Corporation is recalling ShockPulse-SE Lithotripsy Systems (Model SPL-SR) because the generator may get stuck in a blinking state and fail to recognize the reusable probe. This can happen if the probe plug or generator connection becomes damaged. The device is used in hospitals and medical facilities to break up kidney stones and similar calculi.

Roche Diagnostics' cobas pro automated laboratory analyzer has a software defect that can cause it to accept incorrect calibrations. When this happens, the machine repeats the same result for multiple patient and quality-control tests instead of calculating new values, potentially leading to inaccurate lab results. This affects specific blood tests including ferritin, vancomycin, and light chain measurements.

GE Healthcare has identified a software issue in certain versions of its Centricity Universal Viewer Zero Footprint Client where patient information displayed in the viewer may not match the medical images being shown. This could occur in specific workflows on systems with Patient Timeline installed. The issue affects approximately 250 units.

The differential pressure sensor in some Abiomed Impella RP heart pump devices may malfunction, causing inaccurate sensor readings. This affects 179 units distributed worldwide. No injuries have been reported to date.

The differential pressure sensor in some Abiomed Impella RP Flex with SmartAssist heart pump devices may malfunction, causing inaccurate sensor readings. This is a Class I recall affecting approximately 4,496 devices distributed worldwide. No injuries have been reported to date.

The differential pressure sensor in certain Abiomed Impella RP heart pump devices may malfunction and provide inaccurate readings. This could affect the device's ability to monitor and respond appropriately during use. About 291 devices worldwide are affected.

Remel's Campy CVA Medium (lot R01272, UDI 848838001055) is not reliably recovering Campylobacter Jejuni bacteria during laboratory culture testing. Customers reported low to no bacterial growth on this specific lot, which could lead to missed or delayed diagnoses.