183 recalls tagged with “elderly product”.
B. Braun Medical Inc. recalls 26,316 sterile water bags nationwide after discovery of potential leakage from misaligned ports. The recall covers 3000 mL bags with NDC 0264-7385-60. Health care providers are advised to stop use and contact the company for guidance.
LeMaitre Vascular recalls 10 Artegraft Collagen Vascular Grafts distributed internationally to Great Britain and Switzerland, with no US distribution. The devices were labeled incorrectly and lacked CE and UKCA marks and missing patient documents. Healthcare providers and patients should stop using the devices and follow recall instructions immediately.
Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges sold nationwide in the United States. The recall cites a lack of 510(k) premarket clearance to reflect updated sample type for lactate and measurement ranges for pH and PO2. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Frontier Devices and Folsom Metal Products issued a high-risk recall for 490 units of the 16 mm Distraction Pin, REF 301.916S1, distributed nationwide in the United States. The labeling includes shelf life that has not been validated. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 4,841 pacemakers worldwide on 2025-08-20 after a software issue could prevent Safety Mode activation in ambulatory settings. The affected devices include ACCOLADE family pacemakers and VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow the recall instructions in the notification letter.
Boston Scientific recalled 1,380 pacemakers worldwide on August 20, 2025, due to software intended to enhance Safety Architecture. The devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. The defect could prevent initiation of Safety Mode in ambulatory settings. Patients should stop using the devices and follow manufacturer instructions.
Boston Scientific recalled 32,695 ACCOLADE family pacemakers and related CRT-Ps after discovering software that could prevent entering Safety Mode when battery impedance is high. The recall is worldwide and classified as Class I with a high hazard level. Patients should stop using the devices and follow manufacturer instructions. Contact Boston Scientific or a healthcare provider for guidance.
Boston Scientific recalled 3,146 pacemakers worldwide after identifying a software defect that could prevent Safety Mode initiation in an ambulatory setting. Devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. Patients should stop using affected devices and follow manufacturer instructions.
Boston Scientific recalled 7,488 pacemakers worldwide due to software that could impair Safety Mode initiation in high-battery-impedance states. Devices include ACCOLADE family models and CRT-Ps such as VISIONIST and VALITUDE. The issue stems from software designed to enhance Safety Architecture. Patients should follow manufacturer instructions and contact providers immediately.
Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by letter.
Boston Scientific recalled 12,326 ACCOLADE, Visionist and Valitude pacemakers worldwide after a software issue was identified. The software enhances Safety Architecture and may prevent initiation of Safety Mode when battery impedance is high. Patients should contact their healthcare provider immediately and follow the manufacturer’s recall instructions.
Boston Scientific is recalling 3,592 pacemakers sold worldwide through hospitals and clinics in 2025. A software feature intended to enhance Safety Architecture may fail to initiate Safety Mode in ambulatory settings due to high battery impedance. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.
B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.
Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.
Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.
Maquet Cardiovascular recalled 168 Heartstring III Proximal Seal System intravascular occluders worldwide, including the United States. Three failure modes have been identified: loading the Heartstring Seal, deploying it into the aortotomy, and achieving adequate hemostasis. Healthcare facilities should stop using the device and follow the manufacturer’s recall instructions.
Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer recall instructions.
Philips recalled 285 Ingenuity CT systems worldwide, including 728321, 728323 and 728326 models. A ball screw misalignment after a replacement can cause the patient couch to descend to the lowermost position. Hospitals and clinics should stop using the devices and follow Philips recall instructions.
Philips North America has issued a recall for 81 IQon Spectral CT systems, Model 728332, sold worldwide. The patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer recall instructions.
Philips North America recalls 210 CT systems worldwide after reports that the patient support couch may descend unexpectedly to the lowest position following a replacement. Philips issued a recall dated 2025-08-13 with active status. The recall number is Z-2598-2025. Stop using immediately and follow manufacturer instructions.