1084 alerts recorded, refreshed every six hours. Filter by source or category.
Pearle Vision 1 day (somofilcon A) contact lenses from a specific affected lot are recalled. A small number of lenses in that lot have incorrect power, posing a vision hazard to consumers who wear them. Consumers should stop using lenses from the affected lot.
Boston Scientific is recalling its Imager II Angiographic Catheters. The catheter tip may fracture or detach, leaving fragments in the patient or blood vessels, which can cause life-threatening embolism. Patients should contact their healthcare provider to determine if their device is affected and what to do.
Cardinal Health is recalling certain Presource Convenience Kits used in pre-op, NICU, IV, delivery, and other procedures. The kits contain applicators with open or incomplete seals, which may expose patients to contamination and cause skin, soft tissue, or systemic infection. Consumers should stop using the affected kits and contact Cardinal Health for return and replacement instructions.
The recalled product is the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector, model CD-B620LA. The ceramic tip may detach due to insufficient adhesive, posing a risk to patients during procedures. Consumers should contact Olympus for instructions on returning or replacing the device.
AVID Medical, Inc. is recalling Halyard IV START KIT NON-STERILE kits containing BD ChloraPrep Clear - 1 mL Applicator, model KRIV26-02. The applicator packaging may have an open or incomplete seal, exposing patients and healthcare providers to potential contamination or infection. Consumers should stop using these kits and contact AVID Medical, Inc. for return or replacement.
Baxter Healthcare Corporation is recalling its PRO+ 40" MRS SURFACE mattress, model P7924A14. The UDI label has an error that could cause wrong product selection and use with an incompatible bed frame, posing a risk to patients. Consumers should stop using the mattress and follow Baxter's recall instructions for return or correction.
Philips Achieva XR, model numbers 781153 and 781253, are affected. A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted to exceed system memory, exposing patients to an incomplete scan. The recall notice does not specify a consumer action.
DeRoyal Industries is recalling its REF 81-030415 Myocardial Probe Non-Pyrogenic, 400 Series. The probe contains an 18mm needle instead of the correct 15mm needle, which could lead to improper placement or patient injury during cardiac procedures. Users should stop using the affected probes and contact DeRoyal Industries for return instructions.
AVID Medical is recalling Halyard IV START KIT NON-STERILE (model KRIV26-02) containing BD ChloraPrep Clear 1 mL applicator. The applicator may be contaminated with Aspergillus penicillioides, exposing patients to risk of fungal infection during IV insertion. Stop using the recalled kits and contact AVID Medical for return and replacement instructions.
The recall affects New York Embroidery Studio Trinity Non-Surgical Isolation Gowns, model NYES100-2, in X-Large. The gowns may not meet the required liquid-barrier performance, exposing wearers to fluid contact. Consumers should stop using them and contact the firm for instructions.
Ventec Life Systems is recalling its HomeFill Oxygen System cylinder D with CGA870 compatible post valve (REF HF2POSTD). The oxygen cylinders lack required medical gas labeling, which poses a risk of misuse or confusion for patients and caregivers in Florida, Iowa, Ohio, Nebraska, and Tennessee. Consumers should stop using the affected cylinders and contact Ventec Life Systems for instructions on return or replacement.
Heidelberg Engineering is recalling its SPECTRALIS with Flex Module multimodal imaging platforms, models S3610, S2610, S2000, and S1610. The wheels may come loose during movement, causing the stand to tip over and strike the operator or nearby persons, leading to impact or crushing injuries. Consumers should contact Heidelberg Engineering for instructions because the recall is voluntary and firm-initiated.
Medline Industries, LP is recalling 28 Medline Convenience Kits, including spine, craniotomy, and laminectomy packs. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause neurovascular adverse events, fever, inflammation, hypotension, or nausea in patients. Consumers should stop using the affected kits and follow Medline's recall instructions.
Olympus Corporation is recalling its EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm, model BD-420X-1355. The inflation chart label on the device shaft may be incorrect, showing 18, 19, or 20 mm, which could lead to improper balloon sizing for patients during procedures. Consumers should stop using the recalled device and contact Olympus or their healthcare provider for instructions on returning it.
Philips is recalling its Ingenia 1.5T, Ingenia 1.5T CX, and Ingenia 1.5T S MRI systems. A software issue can terminate an exam during image reconstruction if manual scan adjustments exceed system memory, affecting patients undergoing MRI scans. Patients should contact their imaging facility to confirm the software update is applied.
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector, model CD-B610LA, is recalled. The ceramic tip may detach because it was made without the required adhesive, posing a risk to patients during procedures. Consumers should stop using the affected device and contact Olympus for instructions.
Intervascular is recalling its Cardioroot Woven Collagen Coated Vascular Graft in model numbers HEWROOT0024 through HEWROOT0034. The graft may leak blood because it failed water permeability testing, posing a risk to patients undergoing surgery to receive it. Patients and caregivers should contact their surgeon or hospital to confirm whether their device is affected and follow recall instructions.
Philips is recalling its MR 5300 imaging systems, model numbers 782110 and 782152. A software issue can terminate an examination during image reconstruction if scan parameters exceed available memory, affecting patients and operators. Consumers should contact their healthcare provider or Philips for instructions on how to proceed.
Philips MR 7700 and Upgrade to MR 7700, model numbers 782120, 782153, and 782130, are affected. A software issue can stop an exam during image reconstruction when scan parameters exceed system memory, affecting patients undergoing MRI scans. Consumers should contact their healthcare provider or the facility where the scan is performed for instructions.
Biomerieux Inc is recalling its VITEK 2 AST-N461 test kit, reference number 424811, for gram negative susceptibility testing. Damaged card pouches in certain lots may cause false resistant results, leading to less effective antibiotic treatment or harmful side effects for patients. Consumers should stop using affected kits and contact Biomerieux for return and replacement instructions.
Midmark Corporation is recalling its IQvitals Zone device, model 1-200-0320 with kit 4-000-0622. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should contact Midmark Corporation for further instructions.
Criticare Technologies is recalling its nGenuity Patient Monitor with Capnography (ETCO2) models 8100E1 and 8100EP1 series. The monitor may show a Checkline Error alarm during setup, making CO2 monitoring inoperable and delaying procedures for patients and clinicians. Consumers should contact Criticare Technologies for instructions on returning or correcting the device.
Philips is recalling its Ingenia Elition S and Ingenia Elition X MRI systems. A software issue can stop an exam during image reconstruction when scan settings are changed, affecting patients being scanned. Users should contact Philips or their imaging facility for a software update.
Fresenius Medical Care Renal Therapies Group, LLC is recalling its CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Model 03-2522-1. The recall is a communication to review the instructions for use because improper preparation or handling could affect treatment for patients and healthcare providers using the device. Consumers must review the instructions for use and ensure all treatment preparation and handling steps are performed as instructed.
The Midmark IQvitals Zone, model 1-200-0350 with kit 4-000-0722, is affected. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should follow the voluntary recall initiated by Midmark Corporation.
CooperSurgical's INCA Neonatal Nasal CPAP Replacement Set with Stay-Flex tubing, models 44-0712, 44-0707, 44-0709, and 44-0715, is affected. The tubing may have a loose
Abiomed's Automated Impella Controller (AIC) is recalled, including packaged models for CA, EU, UK, US, and optical versions. Firmware and software defects can cause inaccurate pressure signals, unreliable placement signals, unresponsive start keys, and false alarms, exposing patients to potential harm. Consumers should contact their healthcare provider to ensure the firmware and software patches are applied.
Philips Achieva 3.0T MRI systems with model numbers 781177, 781277, 781278, 781344, and 781345 are affected. A software issue can stop an exam during image reconstruction when scan parameters are manually adjusted, exposing patients and operators to interrupted procedures. Consumers should contact Philips for correction instructions.
Midmark Corporation is recalling its IQvitals Zone device, model 1-200-03300 with kit 4-000-0624, which measures blood pressure, pulse, temperature, and oxygen. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should contact Midmark Corporation for instructions.
Medline convenience kits containing Healthmark Instrument Channel Brushes, specifically Sinus Pack DYNJ48258D and DYNJ48258F, are recalled. The brush may have a sharp edge or burr, causing cut injury, abrasion, and infection to users. Consumers should stop using the affected kits.
The recall affects the Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector, model CD-B622LA. The ceramic tip may detach because the device was made without the required adhesive, exposing patients to injury during use. Consumers should follow the recall instructions.
Menow Sunscreen Pressed Powder SPF35 PA+++ from Shantou Qiwei Industry Co. Ltd is recalled. The product has manufacturing practice deviations, exposing users in California to potential health risks. Consumers should stop using it and return or discard it as instructed.
Reliable-1 Laboratories Lubricating Tears sterile eye drops in 0.5 FL OZ bottles are affected. The products lack assurance of sterility, posing a risk to consumers who use them. Consumers should stop using the recalled bottles and follow the recall instructions.
Insight Pharmaceuticals LLC is recalling Clear Eyes Redness Relief Lubricant/Redness Reliever Eye Drops, 0.5 fl oz bottles, distributed nationwide. The eye drops may not be sterile, posing a risk of infection to consumers who use them. Consumers should stop using the recalled product and return or discard it.
Walgreens Lubricant Eye Drops, carboxymethylcellulose sodium 0.5%, sterile 0.5 oz bottles are affected. The hazard is lack of assurance of sterility, exposing users to potential eye infection. Consumers should stop using the product and return or discard it.
The recall affects Major LubriFresh P.M. Nighttime Ointment, 0.125 oz tubes, distributed by Major Pharmaceuticals. The product lacks assurance of sterility, posing a risk to consumers nationwide who use it. Consumers should stop using the ointment and return or discard it according to the recall notice.
Macleods Pharmaceuticals is recalling Olanzapine Tablets, USP 5 mg, 30-count bottles, distributed nationwide in the USA. The tablets contain organic and unspecified impurities above specification, posing a risk to patients taking this medication. Consumers should stop using the affected product and contact their doctor or pharmacist for guidance.
Amneal Pharmaceuticals is recalling Exenatide Injection, USP, 250 mcg/mL, 1.2 mL prefilled pens. The pens may have a defective delivery system and contain no medication, exposing patients to missed doses. Consumers should stop using the recalled pens and contact their pharmacist or Amneal for instructions.
Walgreens Lubricant Eye Drops, sold as a 2-count twin pack of 0.5 FL OZ (15 mL) and 1.0 FL OZ (30 mL) bottles, are being recalled by Sterling Pharmaceutical Services. The products lack assurance of sterility, posing a risk of eye infection for consumers who use them. Consumers should stop using the recalled eye drops and return them to the store or follow the recall instructions.
Reliable-1 Laboratories is recalling its Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles. The product lacks assurance of sterility, posing a risk of eye infection to consumers who use it. Consumers should stop using the recalled solution and return it to the place of purchase or contact the firm.
Cameron Pharmaceuticals is recalling Lubricant Eye Drops, carboxymethylcellulose sodium 0.5%, in 0.5 FL OZ (15 mL) bottles. The eye drops lack assurance of sterility, posing an infection risk to consumers who use them. Consumers should stop using the recalled product and return or discard it as directed by the recall notice.
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lubricant eye drops, distributed by AVKARE, are recalled nationwide. The sterile eye drops lack assurance of sterility, posing a risk of infection to users. Consumers should stop using the product and follow the firm's recall instructions.
Insight Pharmaceuticals LLC is recalling Clear Eyes Redness Relief Lubricant/Redness Reliever Eye Drops, 0.5 fl oz bottles. The products lack assurance of sterility, posing a risk to consumers nationwide in the USA. Consumers should stop using the recalled eye drops and follow the firm's recall instructions.
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lubricant eye drops, sold as a sterile 2-count twin pack, are affected. The product lacks assurance of sterility, posing a risk of eye infection to consumers nationwide who use these drops. Consumers should stop using the recalled eye drops and return or discard them according to the recall notice.
Sterling Pharmaceutical Services LLC is recalling TRP The Relief Products Gentle Eyes Lubricant Eye Drops, carboxymethylcellulose sodium 0.5%, sterile eye drops in 0.5 FL OZ bottles. The eye drops lack assurance of sterility, posing a risk of infection to consumers who use them. Consumers should stop using the recalled product and return or discard it.
Elegant Foods, LLC is recalling Pecorino Toscano D.O.P. STAGIONATO cheese wheels, product of Italy, each about 3-4 lbs. The hazard is potential Listeria contamination from dripping condensation in the cooler, affecting consumers who bought the cheese in Wisconsin. Consumers should not eat the recalled cheese and should return it to the place of purchase.
Evergreen Fresh Sprouts LLC broccoli sprouts in 4-ounce clear plastic zip lock bags are recalled. The sprouts may be contaminated with Salmonella, posing a risk to consumers who purchased them. Consumers should not eat these sprouts and should discard them or return them to the place of purchase.
The recall affects So Delicious Dairy Free Salted Caramel Cluster Cashewmilk frozen dessert in 16 oz tubs. The product may contain small stones and other hard objects, posing a choking or injury risk to consumers. Consumers should not eat the recalled dessert and should return or discard it.
The recall affects United, Crystal Sugar, and Good & Gather powdered sugar in various package sizes. The products may contain wheat kernel contamination, which poses a risk to consumers who consume them. Consumers should check the recalled item numbers and UPCs listed in the notice to see if their product is affected.
United Sugar Producers and Refiners recalled light brown sugar under United and Good & Gather brands. The sugar may contain wheat kernels, which poses a risk to consumers with wheat allergies. Consumers should not eat the recalled sugar and should return it to the store or discard it.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.