2024 Product Recalls
4,022 recalls issued in 2024.
Showing 3901–3920 of 4,022 recalls
Centricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.
Overloaded Electrical System May Cause Fire
Overloaded electrical circuits can overheat, increasing the risk of fire.
SVI Trucks will work with Weldon to update the firmware, free of charge. Owner notification letters were mailed January 16, 2024. Owners may contact SVI Trucks customer service at 1-888-784-1112.
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
ICU Medical notified customers, via Stericycle, Inc., on about 07/29/2019 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Customers were instructed to check inventory and quarantine any sets that are affected by the recall, return them to ICU Medical, inform potential users within your organization of the recall, and complete and return the provided response form. Please notify customers if affected product was further distributed and request that they contact Stericycle at 1-855-311-5437 (M-F, 8am-5pm ET) to receive a reply form. Customers were also requested to consider the following situations: 1. In applications where the use of a filter is not deemed necessary, consider utilizing an administration set without a filter. 2. In applications where filter use is desired and microbore tubing is not required, consider using filtered macrobore sets in place of microbore sets. 3. In cases where a filtered macrobore set is desired but no alternative macrobore set is available contact ICU Medical because a non-filtered set along with an add on filter or filtered extension set could be considered. 4. In instances where the benefits of a filtered microbore infusion set are greater than the potential risks of a filter leak, the product affected by the recall may be utilized out of medical necessity. In these cases, an individualized assessment of benefits and risks should be undertaken with consideration of the unique characteristics of the patient and the infusion itself. When the benefits exceed the risks and the set is deemed medically necessary, users should periodically monitor the vented filter area for leakage. If leaking is observed, consider changing to a new infusion set as soon as clinically appropriate. Report this event to ICU Medical.
Unity Total Knee System. Used for knee prosthesis in total knee replacement
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to vigilance@coringroup.com. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to vigilance@coringroup.com.
Synaptive Trackable Suction Set Standard and Malleable
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
On April 23, 2021 the firm sent a letter to its consignees with the following instructions: 1. Quarantine and discontinue use of all Synaptive Trackable Suction devices. 2. Contact Synaptive Recall Support at 1.866.853.8001 or by email at RecallSupport@synaptivemedical.com. Customer service will schedule an on-site inspection of each device. If this is not possible, arrangements will be made to have all impacted units returned to Synaptive. 3. Once on-site inspection or return of your stock has been arranged, please complete and return the attached Acknowledgement and Receipt Form. All forms should be submitted by email to RecallSupport@synaptivemedical.com. Note: If you are in North America and your account is supported by a Synaptive Clinical Applications Specialist (CAS), then a company representative may have already visited your site and conducted the necessary inspections. If so, we kindly ask that you still complete the Acknowledgement and Receipt Form for our records. 4. Upon inspection, all units will be graded as pass or fail. Units that pass meet normal specifications and are safe for continued use. These devices will be returned and released back into circulation. Failing (i.e. defective) units will be removed immediately and replaced by Synaptive at no cost.
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
The spreader bar can disconnect from the scale bottom attachment.
Customers identified as owners of the affected scales will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice. Affected customers need to ensure that all caregivers and users of the affected devices are made aware of the Field Safety Notice. There will be two options for customers: - Contact Arjo to order parts and instruction required to proceed with the disconnection of the affected scale by on-site biomed personnel to continue to use the ceiling lift safely, or - Contact Arjo to ask to an Arjo service technician to visit a customer facility to perform the scale disconnection to continue to use the ceiling lift safely. The Field Safety Notice will be accompanied by Customer Response Form. Following its return to the local Arjo office and the availability of the permanent solution, a customer will be contacted to complete the action.
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact laura.storms@olympus.com for additional information.
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.
The firm notified the major distributor who received this product on or about 06/14/2018 via a letter entitled "URGENT: Voluntary Medical Device Recall for Clarity 10SG Urinalysis Reagent Strips". The distributor letter stated effective immediately, the purpose of this letter is to advise that Clarity Diagnostics LLC is voluntarily recalling Clarity 10SG Strips Lot# URS7100027EX, Exp:11/2019 , URS7100140EX, Exp:11/2019 and URS8010016EX, Exp: 03/2020. The affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers which is why the recall is being performed. The letter also stated to ensure that communication is relayed to Clarity Diagnostics customers. Once the three lots have been secured, Clarity Diagnostics will follow up with the distributor regarding the disposal of the product. Clarity Diagnostics provided a telephone number for any customer concerns. Clarity Diagnostics has taken appropriate steps to assure that this problem will not reoccur in the future. Clarity Diagnostics also provided a letter to the distributor on or about 06/22/2018 entitled "URGENT PRODUCT RECALL". This letter was provided for distributor to notify its customers. This letter provided notification of a product recall regarding specific lots of Clarity Diagnostics - 10SG Urinalysis Reagent Strips. This notice has been issued because the affected lots are not compatible for use in the Clarity Urocheck 120 Urine Analyzers. Affected product first shipped April 5, 2018. Questions can be directed to the Clarity Diagnostics individual handing the recall---Ashish Parikh at Clarity Diagnostics (877) 722-6339.
Engine Compartment Fire from Short Circuit
A short circuit increases the risk of a fire.
Altec will inspect and relocate the cables and fuse blocks, free of charge. Owner notification letters are expected to be mailed March 8, 2024. Owners may contact Altec customer service at 1-877-462-5832. Altec's number for this recall is CSN-3142.
Front-Drive Unit May Leak Oil and Cause Fire
A fire increases the risk of injury.
GM will replace the vehicles, free of charge. Owner notification letters were mailed January 24, 2024. Owners may contact GM customer service at 1-888-988-7267. There is one fleet customer that owns the vehicles so they are under warranty and reimbursement is not being offered. BrightDrop owners may contact customer service number 888-987-4377. GM's number for this recall is N232466420.
Incorrect Weld May Cause Seat Failure/FMVSS 207
A loose or detached seat assembly increases the risk of injury.
Villa International will work with the affected vehicle manufacturers to inspect for a missing weld and replace the pedestal, as necessary, free of charge. Owner notification letters are expected to be mailed January 15, 2024. Owners may contact Villa International customer service at 1-888-707-7272.
Delay in Park Brake Engagement/FMVSS 121
Unintentional vehicle movement can increase the risk of a crash or injury.
DTNA will inspect and replace the inversion valves, as necessary free of charge. Owner notification letters were mailed February 27, 2024. Owners may contact DTNA customer service at 1-800-547-0712. DTNA's number for this recall is FL992.
Overloaded Electrical System May Cause Fire
Overloaded electrical circuits can overheat, increasing the risk of fire.
Pierce will work with the equipment manufacturer Weldon to update the firmware, free of charge. Owner notification letters were mailed February 26, 2024. Owners may contact Pierce customer service at 1-888-974-3723. Pierce's number for this recall is Pierce 74B332.
Evaporator coil drain pans Recalled for Fire Hazard
The molded plastic drain pan located at the bottom of the evaporator coil can overheat, melt and deform, posing a fire hazard.
Consumers should contact Daikin Comfort Technologies Manufacturing L.P. (DCT) to determine whether your unit is included in this recall and to register for the free repair by a qualified technician. DCT is contacting all registered consumers where records indicate their gas furnace system is subject to the recall.
Scout Kid's Bike Helmets Recalled for Fire Hazard
The molded plastic drain pan located at the bottom of the evaporator coil can overheat, melt and deform, posing a fire hazard.
Consumers should immediately stop using the recalled helmets and contact Retrospec for a full refund. To receive a refund, consumers should destroy the helmet by cutting off the straps and mark the helmet with their initials and the date near the Retrospec logo on the right side of the helmet. Consumers should upload a photo of the helmet, showing the straps cut off, their initials, date, and Retrospec logo, to the recall registration page at https://retrospec.com/pages/retrospec-scout-recall to prove destruction, and then dispose of the recalled helmet.
New Age Industries ("New Age") Furniture tip kits or ti Recalled for Entrapment Hazard
The plastic zip tie used with the recalled furniture tip kits can become brittle or break, which can allow a clothing storage unit that is anchored to the wall to detach during a furniture tip-over event, posing a tip-over and entrapment hazard that can result in death or serious injuries to children.
Consumers should immediately check if their clothing storage unit has a date of manufacture sticker or stamp of November 2019 or later. If so, and if the tip kit is made of plastic, consumers should contact Alliance4Safety for a free replacement tip kit. Keep children away from the unit while waiting for a replacement tip kit.
Justin Boots Keaven WP Met Guard Work Boots Model SE457 Recalled for Safety Concern
The work boots can be missing the metatarsal guard, posing an impact hazard to the user's feet.
Consumers should immediately stop using the recalled boots and contact Boot Royalty Company for instructions on how to receive free replacement boots.
Coolant Heater May Fail to Defrost Windshield
A high voltage coolant heater that fails to defrost the windshield can reduce the driver's view, increasing the risk of a crash.
Lucid will update the software to identify a high voltage coolant heater failure and provide a warning to the driver. High voltage coolant heaters that fail will be replaced. Repairs will be performed free of charge. Owner notification letters were mailed March 7, 2024. Owners may contact Lucid customer service at 1-888-995-8243. Lucid's number for this recall is SR-24-01-0.