602 alerts recorded, refreshed every six hours. Filter by source or category.
Nipro Renal Solutions USA is recalling Citric Complete Liquid Citric Acid Concentrate in refs LC+200-D, LC+201, and LC+225(45X). The concentrate contains high endotoxin levels, posing a risk to hemodialysis patients. Consumers should stop using the recalled product and follow the company's recall instructions.
Getinge PVC Thoracic Catheters, firm PVC straight, in sizes 28FR and 36FR, are affected. The catheters may contain bacterial endotoxin, posing a risk of infection or reaction to patients. Consumers should stop using the affected catheters and contact Getinge or their healthcare provider for instructions.
C.R. Bard is recalling certain Foley and intermittent catheter trays that include Pericare Wipes. The wipes may be contaminated on their surface, posing a risk to patients who use these urological devices. Consumers should stop using affected trays and follow the recall instructions for return or replacement.
The recall affects HeartSine Technologies' SAM 350P, 360P, and 450P defibrillators sold worldwide including the U.S. A damaged membrane tail can cause intermittent faults, exposing cardiac arrest patients to device failure. Consumers should contact HeartSine Technologies for instructions on returning or repairing affected devices.
C.R. Bard Inc is recalling products containing Pericare Wipes, including Bard Foley Tray with Lubri-Sil All-Silicone Foley Catheter and other catheter tray systems. The wipes have surface contamination, exposing patients using these catheter trays to potential infection. Consumers should consult the FDA recall notice for instructions on affected products.
Getinge PVC Thoracic Catheter, Soft PVC Straight, in sizes 16FR to 36FR, is affected. The hazard is an out-of-specification bacterial endotoxin test result in a single lot, exposing patients nationwide. Consumers should be aware that the recall is voluntary and firm-initiated.
C.R. Bard Inc. is recalling SureStep Foley Tray Systems and SureStep Intermittent Catheter Tray that contain Pericare Wipes. The wipes may have surface contamination, exposing patients to possible infection during urological use. Consumers should stop using affected products and contact C.R. Bard for return instructions.
The Lutronic DermaV Laser System is affected. Using higher fluences at 1064nm with current cryogen settings can cause a spark or loud noise, potentially burning patients. Consumers should contact Lutronic Corporation for recall instructions.
Nipro Renal Solutions USA Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate REF BC-100 and BC+201. The concentrate has high endotoxin levels, posing a risk to hemodialysis patients. Consumers should stop using the recalled product and follow the firm's recall instructions.
Medline Industries is recalling its Convenience Kits, including blood draw, phlebotomy, and blood culture kits. The kits' sterile packaging may be compromised by wrinkles in the paper lidding, exposing patients and users to microbial contamination. Consumers should consult the FDA recall notice for instructions.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, with multiple catalog numbers affected. The wipes may be contaminated with a lubricant, causing localized skin irritation, erythema, or mild inflammation in patients. Consumers should check the recall notice for affected catalog numbers and follow the manufacturer's instructions.
Medline Industries recalled its Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, sold as PAIN PRE OP KIT DYKS1476A. The applicator packaging may have an open or incomplete seal, exposing patients to risk of skin, soft tissue, or systemic infection. Consumers should stop using the affected kits and contact Medline for instructions on returning the product.
Medline Industries is recalling three Convenience Kits: ORTHO ASPIRATION KIT DYKM1636A, SHOULD BLOCK KIT DYKM1881A, and TRIMA KIT DYNDB3077C. The kits contain applicators whose packaging may have wrinkles that break the sterile seal, exposing patients and users to microbial contamination and possible infection. Consumers should stop using the recalled kits and contact Medline Industries for instructions on returning or replacing them.
AVID Medical is recalling numerous surgical kits containing Medicom Ritmed Neurological Sponges, non-sterile models 55992C to 55998C. The sponges may have unexpected variability in endotoxin levels, posing a risk to patients during surgical procedures. Consumers should stop using affected kits, check the recall notice for specific lots, and contact AVID Medical for instructions.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, catalog number PBOCGLN17. The wipes may be contaminated with a lubricant, which can cause skin irritation, erythema, or mild inflammation in patients. Consumers should stop using the affected product and follow the recall instructions.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays, specifically the KIT, LUNG TX CIRCULATOR with catalog number OVC3507231. The wipes may be contaminated with a manufacturing lubricant, which can cause localized skin irritation, redness, or mild inflammation in patients. Consumers should stop using the affected wipes and contact Cardinal Health for further instructions.
Boston Scientific is recalling its LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System server software, model 7246, all versions. The software may delay AF Burden Alert notifications, which could delay clinical evaluation or treatment for patients with atrial arrhythmias. Consumers should contact their healthcare provider or Boston Scientific for instructions on how to proceed.
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators are affected. The hazard is an open or incomplete seal on the applicator packaging, which may lead to infection in patients using the kits. Consumers should stop using the affected kits and contact Medline for instructions.
Boston Scientific's LUX-Dx, LUX-Dx II, and LUX-Dx II+ Insertable Cardiac Monitor System with server software model 7248 is affected. The software may delay AF Burden Alert notifications, which could delay clinical evaluation or treatment for patients with atrial arrhythmias. Consumers should contact their healthcare provider to discuss the recall and any needed follow-up.
Medline Industries, LP is recalling its Arterial Line Insertion Kit, model ART1295, part of its Convenience Kits. The kits contain applicators with a potential sterility breach due to wrinkles in the paper lidding, exposing patients and users to microbial contamination that could cause infection. Consumers should stop using the affected kit and contact Medline Industries for instructions.
Medline Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, C-SECTION PREP DYNJ32702B, are affected. The applicator packaging may have an open or incomplete seal, risking infection for users. Consumers should stop using affected kits and contact Medline for return or replacement.
Philips Brilliance CT systems, including models iCT, iCT Upgrades, and iCT SP with software 4.1.10.x, are affected. The systems have an unintended radiation issue that could affect equipment performance, exposing patients to potential risk. Consumers should contact their healthcare provider or Philips for instructions on what to do.
Medline Industries is recalling its Convenience Kit COLORECTAL ME, model DYNJ906437D. The kit's sterile packaging may have wrinkles that allow microbial contamination, exposing patients and users to possible infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.
B Braun Medical Inc is recalling its Extension Set, the Discofix Four Way Stopcock, model 456025. The hazard is an incorrect expiration date printed on the carton shipper label, exposing users to potentially expired products. Consumers should check if their product is affected and follow the recall instructions from B Braun.
Fresenius Medical Care is recalling its 5008X HD/HDF with CLiC Blood Tubing Set, part number 03-5300-3C. A blood leak can occur at the connection between the Arterial Alpha Clip and the main line or pump segment, risking blood loss and hypovolemia for patients during dialysis. Consumers should check the part number and contact Fresenius or their dialysis provider for instructions.
Medline Industries is recalling Medline Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, specifically the Ortho Aspiration Kit DYKM1636A. The applicator packaging may have an open or incomplete seal, risking contamination and causing skin, soft tissue, or systemic infections for patients using the kits. Consumers should stop using the affected kits and contact Medline for instructions on return or replacement.
Medline Industries is recalling its Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, specifically the Blood Culture Kit 2 with Connect DYNDH1487A. The applicator packaging may have an open or incomplete seal, potentially causing contamination that can lead to skin, soft tissue, or systemic infections in users. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Cardinal Health's Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays are affected, with catalog numbers PGOCRDNHD, PG36RPEAB, and PVCGVTACF. The wipes may be contaminated with a lubricant, causing skin irritation, erythema, or mild inflammation in patients. Consumers should check for the affected catalog numbers and follow the voluntary recall initiated by the firm.
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators, including specific pre-op kit models, are affected. The applicator packaging may have an open or incomplete seal, exposing patients to potentially contaminated applicators that can cause skin, soft tissue, or systemic infections. Consumers should stop using affected kits and follow the recall instructions from Medline.
Medline Industries is recalling several Medline Convenience Kits, including PRE-OP and GENERAL PREOP kits with specific catalog numbers. The kits contain applicators with a potential breach of sterility, exposing patients and users to microbial contamination that could cause infection. Consumers should stop using the affected kits and contact Medline Industries for further instructions.
Medline Industries is recalling Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators, specifically BASIN PACK-LF DYNJ42828B and EYE BASIN TRAY-LF DYNJ42832B. The applicator packaging may have an open or incomplete seal, exposing users to potentially contaminated applicators that can cause skin, soft tissue, or systemic infections. Consumers should verify their kit's lot number and follow the firm's voluntary recall instructions.
Medline Convenience Kits containing BD ChloraPrep Clear 1mL Applicators, including patient admin kits DYKA1384B, DYKA1384C, and welcome kit DYKS1206D, are affected. The applicator packaging may have an open or incomplete seal, exposing patients to risk of skin, soft tissue, or systemic infection. Consumers should stop using affected kits and follow the recall instructions.
Medline Industries is recalling certain Convenience Kits that contain BD ChloraPrep Clear 1mL Applicators. The applicator packaging may have an open or incomplete seal, which could expose patients to contaminated applicators and cause skin, soft tissue, or systemic infections. Consumers should stop using the affected kits and contact Medline Industries for instructions on returning or replacing them.
Medline Industries is recalling two Convenience Kits: Drawer 9 Cricothyrotomy Kit (ACC010741) and Anesthesia L&D A-Line Set (DYKMBNDL199A). The kits contain ChloraPrep and FREPP applicators with packaging wrinkles that may breach sterility, exposing patients and users to
Medline Industries is recalling two IVS Blood Culture Kits, models DYNDH1920 and DYNDH1920A. The kits contain applicators whose packaging may have wrinkles that break sterility, exposing patients and users to microbial contamination and possible infection. Consumers should stop using the kits and follow the firm's recall instructions for return or replacement.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays. The wipes may be contaminated with manufacturing lubricant, causing skin irritation, erythema, or mild inflammation in patients. Consumers should check the catalog numbers and contact Cardinal Health for further instructions.
Philips IQon Spectral CT systems (codes 728332 and 728331, software 4.7.7.x) are affected. An unintended radiation issue could affect equipment performance, exposing patients to risk. The FDA-mandated recall requires consumers to follow the recall notice.
Medline Industries, LP is recalling multiple Medline Convenience Kits, including catalog numbers CDS840396X, CDS840396Y, CDS983348AA, CDS983348AB, CDS983672O, CDS983672P, DYKM1982, DYNDA1080, DYNJ67490C, DYNJ907400D, and DYNJ908990A. The kits contain applicators with a potential breach of sterility in the packaging, exposing patients and users to microbial contamination that could cause infection, serious illness, or hospitalization. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Medline Industries is recalling certain Medline Convenience Kits, including IV start kits, blood culture kits, and pediatric emergency trays, with specific catalog numbers. The kits contain BD ChloraPrep Clear and FREPP Clear applicators that may have a sterility breach due to wrinkles in the paper lidding, exposing patients and users to microbial contamination and possible infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Medline Industries is recalling certain Convenience Kits, including Eye Kit models DYKM2751 and DYKM2751A and Cataract Preop Kit models DYKS1583A and DYKS1583B. The kits contain applicators with a possible sterility breach that could expose patients and users to microbial contamination, risking infection. Consumers should stop using the affected kits and contact Medline Industries for instructions.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays, including specific catalog numbers. The wipes may be contaminated with a lubricant, causing localized skin irritation, erythema, or mild inflammation in patients. Consumers should stop using the affected trays and contact Cardinal Health for further instructions.
Medline Industries is recalling several Medline Convenience Kits, including IV Start and IV Blood Culture kits, with specific model numbers. The kits contain applicators whose packaging may have a sterility breach, exposing patients and users to microbial contamination that could cause infection. Consumers should check the recalled model numbers and follow the firm's recall instructions.
Medline is recalling certain Convenience Kits that contain BD ChloraPrep Clear 1mL Applicators. The applicator packaging may have an open or incomplete seal, risking contamination and possible skin, soft tissue, or systemic infection for patients. Consumers should stop using affected kits, check the recalled lot numbers, and contact Medline for replacement or return.
Fresenius Medical Care Renal Therapies Group, LLC is recalling its 5008X HD/HDF Standard Blood Tubing Set, part number 03-5300-3. The tubing can leak blood at the connection between the Arterial Alpha Clip and the main line or pump segment, risking blood loss and hypovolemia for dialysis patients. Consumers should stop using the affected sets and contact Fresenius Medical Care for replacement instructions.
Medline Industries is recalling its Medline Convenience Kit C-SECTION PREP, model DYNJ32702B. The kits contain applicators with a possible sterility breach, exposing patients and users to microbial contamination that could cause infection. Consumers should stop using the affected kits and follow the recall instructions from Medline or the FDA.
Cardinal Health Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays are affected. The wipes may be contaminated with a lubricant, which can cause skin irritation, redness, or mild inflammation in patients. Consumers should check for the recalled catalog numbers and contact Cardinal Health for instructions.
Fresenius Medical Care Renal Therapies Group, LLC is recalling Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis with product numbers 08-2251-CA, 08-3251-CA, and 13-2251-CA. The product may have blue-green discoloration, posing a hazard to patients undergoing hemodialysis. Consumers should check their product numbers and follow the recall instructions from the company.
Cardinal Health 200, LLC is recalling Presource Packs containing CliniClean Pericare Wipes inside BD Urinary Catheter Trays, with specific catalog numbers. The wipes may be contaminated with a manufacturing lubricant, posing a risk of skin irritation, erythema, or mild inflammation to patients. Consumers should identify affected catalog numbers and follow the voluntary recall instructions from Cardinal Health.
Fresenius Medical Care is recalling NaturaLyte, a liquid acid concentrate for bicarbonate hemodialysis, with specific product numbers. The product may show blue-green discoloration, posing a risk to patients receiving dialysis. Consumers should stop using the affected product and follow the recall instructions.
The affected product is the Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL. A software issue during multi-syringe infusion when a syringe is replaced while volume remains poses a hazard to patients using the pump. The recall is voluntary and firm-initiated, so consumers should follow the recall notice.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.