2021 Product Recalls

Drive Chain May Break Causing Loss of Drive Power

An improperly secured drive chain may slip and break, causing a loss of drive power and increasing the risk of a crash.

Dealers will reprogram the TCU, inspect TCU data for chain slip, and visually inspect the chain guide. If evidence of chain slippage or damage is found, the transmission will be replaced. Repairs will be performed free of charge. Owner notification letters were mailed August 19, 2022. This recall includes all vehicles previously recalled under 19V-855. Vehicles previously recalled under 19V-855 will need to have the new remedy performed for this recall once available. Owners may contact Subaru customer service at 1-844-373-6614. Subaru's number for this recall is WRK-21.

Tie Rods May Separate

The tie rods may separate from the housing, causing a loss of steering control and increasing the risk of a crash.

Dealers will replace the left and right front tie rod ends and housings, free of charge. Owner notification letters were mailed February 7, 2022. Owners may contact Subaru customer service at 1-844-373-6614. Subaru's number for this recall is WRL-21.

Parking Brake May Release Unexpectedly

The unexpected release of the parking brake may allow the vehicle to rollaway, increasing the risk of a crash.

Dealers will remove the exhaust tube and fitting from the valve, free of charge. Owner notification letters were mailed February 8, 2022. Owners may contact Mack customer service at 1-800-866-1177. Mack's number for this recall is SC0433.

Fuel Tubes May Crack and Leak Fuel

A high pressure fuel leak in the presence of an ignition source can increase the risk of a fire.

Dealers will replace the fuel tubes and install vibration isolators, free of charge. Owner notification letters were mailed February 14, 2022. Owners may contact E-One customer service at 1-352-237-1122.

CPSC Dec 10, 2021

Letters to Santa Mailbox Recalled for Laceration Hazard

The mail slot on the mailbox can be sharp, posing a laceration hazard.

Consumers should immediately stop using the recalled mailbox and return it to any Target Store for a full refund in the form of a Target gift card. Consumers can also contact Target to receive a prepaid return label to return the mailbox for a full refund in the form of a Target gift card.

smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out.

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

On 10/11/2021, the Firm sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)" Notfication via UPS informing customers that breast implants which have expiration dates from 01/01/2025 to 09/30/2021, due to a manufacturing issue may have a potentially weakened area on the base patch portion of the shell. As a result of this issue, these implants may prematurely deflate for which replacement surgery may be needed. Customers are instructed to: 1. Examine inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax/email to Sedgwick at 888-912-7086 or mentor7209@sedgwick.com within 3 business days. Return the BRF even if they do not have product subject to this recall. 5. Follow instructions in the letter and immediately return any inventory of MENTOR Smooth Round Saline DV Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall to Sedgwick. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. While processing the returns, maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 7. Return unused impacted Breast Implants with expiration dates ranging from 01/01/2025 to 09/30/2025 subject to this recall that are in their inventory immediately. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the dat

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

Potential for open packaging seals compromising the sterility of the surgical gowns

Cardinal Health issued Urgent Medical Device Recall Letter dated November 2, 2021, stating reason for recall, health risk and action to take: 1) REVIEW your inventory for affected product. 2) SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Attachment 1. 3) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 4) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. 5) CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other Customers 888-444-5440 6) CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Available Assistance: Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other customers 888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

The incorrect Loctite adhesive was used to assemble the impactor heads.

The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.

Front Ceiling Panel May Come Loose and Fall

A falling ceiling panel may distract the driver, increasing the risk of a crash, or strike a vehicle occupant, increasing the risk of injury.

Prevost Service Centers will reinforce the panel, free of charge. Owner notification letters were mailed December 17, 2021. Owners may contact Prevost customer service at 1-866-870-2046. Prevost's number for this recall is SR21-12.

Inoperable Headlights/FMVSS 108

Inoperable headlights can reduce visibility for the driver and oncoming traffic, increasing the risk of a crash.

Dealers will reprogram the SLM software, free of charge. Owner notification letters were mailed December 23, 2021. Owners may contact FCA US, LLC customer service at 1-800-853-1403. FCA US, LLC's number for this recall is Y72.

Missing Odometer Display/FMVSS 101

A missing odometer reading could lead to an unintended delay in critical safety-related maintenance, potentially impairing the safe operation of the vehicle and increasing the risk of a crash.

Dealers will update the instrument panel cluster (IPC) software on vehicles with less than 13,342 miles, and replace the IPC on vehicles in which the mileage is not displayed, free of charge. Owner notification letters were mailed December 28, 2021. Owners may contact FCA US, LLC customer service at 1-800-853-1403. FCA US, LLC's number for this recall is Y94.

Stove Saddle Valves May Leak Gas

A gas leak can increase the risk of a fire.

Carson will work with Dometic, and dealers will install a remedy kit of gaskets, washers, thread locker bolts, and two round orange labels, free of charge. Owner notification letters were mailed November 12, 2021. Owners may contact Carson customer service at 310-516-6046. Carson's number for this recall is Recall4.

Control Module Shutdown Can Reduce Engine Power

A gateway control module shutdown will suddenly reduce engine power, increasing the risk of a crash.

Dealers will install a protective cover on the gateway control module and seal an underbody seam as necessary, free of charge. Owner notification letters were mailed January 21, 2022. Owners may contact Audi customer service at 1-800-253-2834. Audi's number for this recall is 90S9.