2024 Product Recalls

Missing Front Marker Light Reflectors/FMVSS 108

Missing or incorrectly positioned lights and reflectors can reduce the trailers visibility to other drivers, increasing the risk of a crash.

Owners are advised to limit on-road use while operating without a trailer until the remedy is available. Orange EV will install front side marker lights and relocate the front reflectors, free of charge. Owner notification letters were mailed August 15, 2025. Owners may contact Orange EV customer service at 1-866-688-5223.

Frame Extenders Obstruct Rear Lights/FMVSS 108

Obstructed rear lights can reduce the vehicle's visibility to pedestrians or other drivers, increasing the risk of a crash.

Owners are advised to limit on-road use while operating without a trailer until the remedy is completed. Interim owner notification letters explaining the safety risk were mailed February 21, 2025. A second notice will be sent once the remedy is available. Owners may contact Orange EV customer service at 1-866-688-5223.

Beavertail Frame Obstructs Reverse Lights/FMVSS108

Obstructed reverse lights can reduce the vehicle's visibility to pedestrians or other drivers, increasing the risk of a crash.

Owners are advised to limit on-road use while operating without a trailer until the remedy is completed. Orange EV will replace and relocate the reverse lights, free of charge. Owner notification letters were mailed August 15, 2025. Owners may contact Orange EV customer service at 1-866-688-5223.

Missing Seat Mounting Bolts

Seats without mounting bolts may not properly restrain an occupant, increasing the risk of injury.

Dealers will inspect and install mounting bolts as necessary free of charge. Owner notification letters were mailed January 24, 2025. Owners may contact Kia customer service at 1-800-333-4542. Kia's number for this recall is SC329.

Mounting Brackets May Damage Air Bag FMVSS/214/226

An air bag that is damaged during deployment can increase the risk of injury in a crash.

Dealers will inspect and if necessary, replace the window airbags, and mounting brackets, free of charge. Owner notification letters were mailed February 7, 2025. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2025010005.

HV Air Compressor Is Not On Protective HVIL Loop

Failure to alert the operator to a power cable issue can increase the risk of injury by electrical shock.

Dealers will install an additional electrical harness, extending the HVIL loop to the air compressor, free of charge. Owner notification letters were mailed February 12, 2025. Owners may contact GILLIG customer service at 1-800-735-1500.

Damaged Fire Suppression Relay Cable May Fail

Failure of the fire suppression system can increase the risk of injury during a fire.

Dealers will replace the relay cable, free of charge. Owner notification letters were mailed December 31, 2024. Owners may contact GILLIG customer service at 1-800-735-1500.

High Pressure Fuel Pump May Fail

High pressure fuel pump failure can cause a loss of drive power, increasing the risk of a crash.

Dealers will update the powertrain control module (PCM) and Transmission Control Module (TCM) software, free of charge. Owner notification letters were mailed January 23, 2026. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 24S78.

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Due to misbranded products shipped to customers.

On September 15, 2021, the firm, BD, sent out an "URGENT MEDICAL DEVICE CORRECTION" letter to their customers and Distributors via FedEx, informing them of the two products, first product or kit had missing component and the second product had extra component of the first product. The firm asked customers/Distributors to take the actions as: 1)Please check all inventory locations within your institution for the product listed in Table A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facilitys destruction process.2.) Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction.3.) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution.4.) Complete and return the attached Customer Response Form to BD Post Market Quality at Email: BDRC20@bd.com or Fax No.: 312-949-0410 confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process your credit. 5.) Please contact your BD representative to assist in this process or you may also contact the number below for further assistance. 6) Issue credit to customers following receipt of the completed customer response form. 7) Firm initiated actions to prevent recurrence of this product issue. The firm asked customers to report any adverse health consequences experienced with the use of this product to the firm and to FDA. The firm provided below contact information as : Contact Information: North American Regional Complaint Center1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT for Recall Questions, Product Complaints, Technical Questions.

Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

On 11/30/2020, the firm emailed an "Urgent Field Safety Notice" to its U.S. Customers informing them that investigations have confirmed that the quality control (QC), high and low controls, provided with specific product and lot numbers are consistently demonstrating a ~15% positive bias compared to assigned values and customers may experience QCs consistently reporting results close to the upper acceptable limits, and QC failures may occur on the affected products. Customer are instructed: 1. Users may continue to use any remaining kits of the affected product in their stock. As per the product package insert sample results obtained should only be accepted if the control results are within +/-20% of the concentrations stated on the QC certificate provided. 2. To complete the E-Back Form TSWS18 to Technical.support@bindingsite.com or to their local representative within one week of receiving this notification. Customers are also instructed: -To pass on the notification to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. -To transfer this notification to other organizations on which the information has an impact. -To maintain awareness on this notification for any appropriate period. Any questions, contact the local representative or Technical Support Group: UK technical support is: Telephone: +44(0) 1214569696 Email: technical.support@bindingsite.com Customers in the USA may choose to instead contact the local representative at: Telephone: 800-633-4484 Us-tsc@Bindingsite.com

putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY

Patient chart label contains incorrect Part Number and volume amount.

On 04/14/2022, Cerapedics, Inc. email a "Medical Device Recall" letter to customer informing them that the firm is voluntarily recalling all units of i-FACTOR 1.0cc Putty from lot 21C0991 due to the incorrect product code on the patient chart label. Customers are asked to: 1) Examine their inventory and return any remaining units from lot 21C0991 using the provided RMA number. 2) Respond to the Recall email or call toll free at 1-866-360-5612 to report the number of units at their location. 3) If the affected product has been further distributed, notify those customers of the recall utilizing the recall notification letter. Questions or assistance - contact Customer Service at 1-866-360-5612.

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Due to a potential failed sterilization process.

On May 16, 2022, Philips sent an "URGENT Medical Device Recall" Letter via email to Philips Sales Representatives who then delivered directly to the affected customer. The Letter informed customers that between 05/04-12/2022, potentially non-sterile products were shipped to customers. Customer are asked to immediately check their product inventory and quarantine any affected products to prevent use. Affected product is requested to be returned to Philips IGTD for replacement products. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: igtdc.r@philips.com For further information or support concerning this issue, contact the local Philips representative: Philips IGTD Customer Service: Phone: 1-800-722-9377, Option 1 Email: IGTD.CustomerInquiry@philips.com Hours of Operation: Monday - Friday 8:00AM 5:00PM PST

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

An Urgent Field Safety Notification was issued November 18, 2020 sent USPS certified mail to distributors regarding removal of Ennovate Removal Key Short (SZ380) from the field. The affected Ennovate MIS Removal Key Short (SZ380R) in the field is to be exchanged with an improved design version under the same article number manufactured after June 01, 2020. Distributors are to identify and notify customers of this action. Distributors and customers are to identify the affected version in inventory and return it to Aesculap and submit the Acknowledgment Form via email at qa-recalls@aesculapusa.com.

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

On 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.

High Voltage Battery May Short Circuit

Battery failure can cause a loss of drive power, increasing the risk of a crash. Battery failure can also increase the risk of a fire.

Owners are advised not to charge battery till the remedy has been completed. Dealers will perform a battery energy control module (BECM) software update, and replace the high voltage battery pack, as necessary, free of charge. Owner notification letters were mailed on May 30, 2025. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 24S79.

Power Windows May Pinch/FMVSS 118

A closing window may exert excessive force by pinching a driver or passenger before retracting, increasing the risk of injury.

Dealers will recalibrate the driver door module (DDM) and the passenger door module (PDM), free of charge. Owner notification letters were mailed on February 28, 2025. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 24C43.

Rearview Camera Image May Not Display

A rearview camera that displays a blank or distorted image can reduce the drivers view of what is behind the vehicle, increasing the risk of a crash.

Dealers will replace the rearview camera as necessary, free of charge. Interim letters, notifying owners of the safety risk, were mailed January 22, 2025. A second notice will be sent once the final remedy is available, anticipated March 2026. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 24S75.

Fuel Tank and Filler Neck Improperly Welded

A fuel leak in the presence of an ignition source increases the risk of a fire.

Dealers will replace the fuel tank assembly, free of charge. Owner notification letters were mailed February 3, 2025. Owners may contact Honda customer service at 1-888-234-2138. Acura's number for this recall is JKX.

Loss of Steering from Front Control Arm Separation

A detached control arm can cause a loss of vehicle steering and control, increasing the risk of a crash.

Dealers will inspect the upper control arm ball joint nut, and replace the nut and/or knuckle assembly, as necessary, free of charge. Owner notification letters were mailed February 10, 2025. Owners may contact Ford customer service at 1-866-436-7332. Ford's number for this recall is 24S76.