2023 Product Recalls
0 recalls issued in 2023.
Valley Meats, LLC, Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
Product Contamination
Simpson Gas Pressure Washers with Electric Start Recalled for Burn Hazard
The lithium battery in the electric start system can overheat, posing a burn hazard.
Consumers should immediately stop using the recalled gas pressure washer and contact FNA Group Inc. for instructions on how to have their unit repaired free of charge at an authorized repair facility. The repair will replace the lithium battery in the electric start system with a sealed lead acid battery.
Relax 5mm Science Kit, Large Hematite Magnets Magnetic Recalled for Poisoning Hazard
The recalled 5mm magnetic ball sets do not comply with the requirements of the mandatory federal magnet regulation because the sets contain one or more magnets that fit within CPSC's small parts cylinder, and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract each other, or another metal object, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning, and death.
Consumers should stop using the recalled magnetic balls immediately, take them away from children and contact Joybuy to receive a pre-paid label to return the recalled products for a full refund. Joybuy is notifying all known purchasers directly.
BlendJet 2 Portable Blenders Recalled for Fire Hazard
The recalled blenders can overheat or catch fire and the blender blades can break off, posing fire and laceration hazards to consumers.
Consumers should immediately stop using the recalled blenders and contact BlendJet for a free replacement of the BlendJet 2 base unit. Consumers will need to remove and cut the rubber seal from the base of their recalled blender into three or more pieces and upload or email a photo showing the serial number on the bottom of the unit and its rubber seal in pieces to BlendJet at www.blendjet.com/safetyandrecall or safety@blendjet.com to receive a free replacement base. Consumers can identify whether they have a recalled unit by entering the serial number of their unit into the "Is my BlendJet 2 Recalled?" tool located at www.blendjet.com/safetyandrecall, or by calling BlendJet toll-free number at 844-334-0562.
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
The firm, inpeco, sent "Urgent: Medical Device Correction" letters dated 7/14/20 to its customers. The letter described the product, problem and actions to be taken. Action to be taken by the user: Be aware that the Secondary Sample Tube flagged with error 2132 or 1442 may be diluted: discard this Secondary Sample Tube or manage it according to your laboratory guidelines. Your service provider will contact you to schedule the upgrade of the software driver and language.ini with the new error message and error recovery displayed if error 2132 or 1442 occurs. Until the service visit please maintain awareness on this notice. Please transfer this notice to whom it might concern. Please complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement form, record the total number of individual units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement a BBMI representative will contact you to arrange for inspection and/or correction of the affected products. Should an issue occur, please report the event promptly to BBMI by contacting Medical Affairs Department at 1-800-854-6851.
Regard brand CABG Pack A and B - Spartanburg
Kits were packed into shipping boxes incorrectly.
An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs.com so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result
Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. How will the corrective action be implemented? Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely. The remote software updates process will require approximately 180 minutes for completion. If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436.
Drag Link May Become Deformed or Break
A broken drag link can cause a complete loss of steering control, increasing the risk of a crash.
Dealers will install a new drag link, free of charge. Owner notification letters were mailed February 1, 2024. Owners may contact Battle Motors customer service at 1-877-546-2537.
Engine Compartment Fire from Short Circuit
A short circuit increases the risk of an engine compartment fire.
Dealers will install sheathing over the wiring, free of charge. Owner notification letters were mailed February 22, 2024. Owners may contact Hyundai customer service at 1-855-371-9460. Hyundai's number for this recall is 252.
Steering Gear Assembled Incorrectly
A loss of steering control increases the risk of a crash.
A dealer will inspect and replace the defective gears as necessary, free of charge. An owner notification letter was mailed February 7, 2024. The owner may contact Volvo Trucks customer service at 1-800-528-6586. Volvo Trucks number for this recall is RVXX2316.
Steering Gear Assembled Incorrectly
A loss of steering control increases the risk of a crash.
Dealers will inspect and replace the defective gears as necessary, free of charge. Owner notification letters were mailed February 9, 2024. Owners may contact Mack customer service at 1-800-866-1177. Mack's number for this recall is SC0457.
Software Error May Cause Unintended Acceleration
Unintended acceleration can increase the risk of a crash.
New Flyer will update the vehicle software, free of charge. Owner notification letters are expected to be mailed February 15, 2024. Owners may contact New Flyer customer service at 1-800-241-2947. New Flyer's number for this recall is R23-022.
Software Error May Cause Unintended Acceleration
Unintended acceleration can increase the risk of a crash.
New Flyer will update the vehicle software, free of charge. Owner notification letters were mailed February 13, 2024. Owners may contact New Flyer customer service at 1-800-241-2947. New Flyer's number for this recall is R23-023.
Rear Axle Hub Bolt May Break
Damaged axle hub splines can result in a vehicle rollaway when the vehicle is in park without the parking brake applied or cause a loss of drive power. Both of these conditions can increase the risk of a crash.
Dealers will replace the left and right rear axle shaft assemblies, free of charge. Owner notification letters were mailed on May 9, 2025. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 23S65.
Vehicle Rollaway from Incorrect Gear Shifter
When shifted into PARK, the transmission will actually be in NEUTRAL, increasing the risk of a vehicle rollaway and crash.
Dealers will inspect and replace the transmission gear shifter, as necessary free of charge. Owner notification letters were mailed April 4, 2024. Owners may contact DTNA customer service at 1-800-547-0712. DTNA's number for this recall is FL991.
Overloaded Electrical System May Cause Fire
Overloaded electrical circuits can overheat, increasing the risk of fire.
Dealers will update the firmware, free of charge. Owner notification letters were mailed February 22, 2024. Owners may contact Rosenbauer America customer service at 1-651-462-1000.
120-Volt Passenger Outlets May Detach
A detached 120-Volt outlet can shock passengers, increasing the risk of injury.
Dealers will install a cavity socket and quadruple screw connection, free of charge. Owner notification letters were mailed February 13, 2024. Owners may contact Daimler Coaches customer service at 1-416-624-3558. Daimler Coaches number for this recall is 54.10T23277A.
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.