The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
All Recalls
95,094 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Cyber vulnerability of BLE communication was found by CISA VDP program.
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
🏥 Medical Devices Class I - Dangerous
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
🏥 Medical Devices Class I - Dangerous
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Philips North America
🏥 Medical Devices Class I - Dangerous
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Healthmark Industries Co.
🏥 Medical Devices Class I - Dangerous
Product does not have FDA clearance.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
catheter may experience resistance when being advanced over the guidewire
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Immuno-Mycologics
🏥 Medical Devices Class I - Dangerous
Neutralization Buffer may contain contaminants
🏥 Medical Devices Class I - Dangerous
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
🏥 Medical Devices Class I - Dangerous
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
🏥 Medical Devices Class I - Dangerous
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
i-STAT EG7+ cartridge; List Number: 03P76-25;
Abbott Point Of Care
🏥 Medical Devices Class I - Dangerous
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
🍎 Food Class I - Dangerous
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Undeclared hazelnut and soy lecithin.
Spice Powder, 4 oz, Plastic Bag
Summit Import
🍎 Food Class I - Dangerous
Lead level was higher than NYSAGM Standard.
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Bulk Horchata Powder 3951 (100547) 1/25 HORCHATA UPC: 042743-19015-0 Item: 100547
Marquez Brothers International
🍎 Food Class I - Dangerous
Undeclared milk.
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Unistel Industries
🍎 Food Class I - Dangerous
Product may be contaminated with Salmonella.