2015 Product Recalls

7,426 recalls issued in 2015.

7,426
Total Recalls
157
USDA
305
CPSC
2,020
FDA Drug
USDA 157 CPSC 305 FDA Drug 2,020 FDA Device 1,140 NHTSA 970 FDA Food 2,834

Showing 41–60 of 7,426 recalls

NHTSA

Wheel Chair Lift Link Arm Pivot Holes

If the bearings move out of position, the stowed platform may have excessive movement resulting in failure of the platform mounting. This failure could cause the wheel chair lift platform to fall out of the vehicle when the doors are opened, increasing the risk of injury for the lift operator.

Navistar will notify the purchasers of the lifts, and dealers will inspect the link arms for damage or for displaced bearings. The platform will be inspected for cracks. Any damaged parts will be replaced, free of charge. The recall began on February 19, 2016. Owners may contact Navistar customer service at 1-800-448-7825. Note: These buses and wheelchair lifts were subject to a similar recall in 2014. All vehicles that received that recall remedy are still affected by this recall as well.
NHTSA

Electric Entry Steps May Become Unstable

Unstable entry and exit steps increase the risk of injury.

Entegra will notify owners, and dealers will install a retainer bracket on the double step assemblies. On the trip step assemblies, the Coachstep linkage Assembly will be replaced and a retainer bracket will be installed. The manufacturer has not yet provided a notification schedule. Owners may contact Entegra customer service at 1-800-945-4787, or Lippert customer service at 1-574-537-8900. Entegra's number for this recall is 9903275.
NHTSA

Seat Belt Assembly Bolt not Properly Tightened

An insufficiently torqued bolt may prevent the seat belt from holding the required load in a crash, increasing the risk of injury.

GM will notify owners, and dealers will inspect and tighten the bolts, free of charge. The recall began on January 27, 2016 Owners may contact Chevrolet customer service at 1-800-222-1020. GM's number for this recall is 15777.
NHTSA

Incorrect Tire Size on Federal Label/Part 567

Over inflated tires may result in sudden tire failure and increase the risk of a crash.

Forest River will notify owners and will provide a corrected Federal placard, free of charge. The recall began on February 17, 2016. Owners may contact Forest River customer service at 1-574-862-3001. Forest River's number for this recall is 49-12182015-0124.
NHTSA

Engine Stall from Loss of Sensor Signal

Without the bank angle sensor signal, the engine may stall while riding, increasing the risk of a crash.

Honda will notify owners, and dealers will relocate the joint connector and replace the bank angle sensor, free of charge. The recall began on January 25, 2016. Owners may contact Honda Motorcycle customer service at 1-866-784-1870. Honda's number for this recall is JW7.
NHTSA

Aluminum Hinges may Break

If the hinge breaks, the gate may open unexpectedly, increasing the risk of a crash.

H&H will notify owners, and dealers will replace the hinges, free of charge. The recall began on January 13, 2016. Owners may contact H&H customer service at 1-712-542-2618.
NHTSA

Electric Entry Steps may be Unstable

Unstable entry and exit steps increase the risk of injury.

ARG will notify owners and dealers will install a retainer bracket to reinforce the operating mechanism, free of charge. The recall began on February 12, 2016. Owners may contact ARG customer service number at 1-800-509-3417. ARG's number for this recall is 151216REV.
NHTSA

ESC Malfunction may cause Loss of Control

If the one or more of the brakes are inappropriately applied, control of the vehicle may be lost, increasing the risk of a crash.

Hyundai will notify owners, and dealers will verify the proper operation of the ESC sensors, and update the ESC system's calibration, free of charge. The recall began June 6, 2016. Owners may contact Hyundai customer service at 1-800-633-5151. Hyundai's number for this recall is 137.
FDA

MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.

Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
FDA

Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.

Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.

*** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.
FDA

Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct information. If you have any remaining inventory, a copy of this communication can be kept with the units for future medical record documentation purposes. If you have already used some of the product lot, you may amend any patient record(s) based upon the content of this communication. Please complete and return the accompanying Effectiveness Check Form attached to this letter regardless of whether or not you have any remaining units of the affected product lot. If you may have further distributed or transferred this product, please identify the respective organizations and notify them of this product communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This product communication is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this may have caused your organization. Please contact the Davol Customer Service Department at 1-800-556-6275 or C.R. Bard Medical Services & Support Department at 1-800-562-0027 if you have any questions.
FDA

cobas Liat Analyzer, for in vitro diagnostic use.

Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.

Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.
FDA Class III

Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98

Labeling: Incorrect or Missing Lot AND/OR Exp Date.
FDA Class I

Single Curry Chicken Salad Wrap, Made Right Here, 7oz UPC 263126

Product contaminated with Listeria monocytogenes
FDA Class I

GORGEOUS MEMORY brand Daylily, NET WT: 10.6 oz. (300 g), UPC 6 932960 968806, Product of China --- MINHANG FOOD CO., LTD, 103 Eldridge St., New York City, NY 10002 --- Nutrition Facts: Serving Size: 1 tbsp (100g), Servings Per Container: 4

The product contained undeclared sulfites (44779 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
FDA Class I

Classic Deli Pasta Salad, Sold by weight UPC 260976

Product contaminated with Listeria monocytogenes
FDA Class II

Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce (French Labeling - Raviolis Au Fromage avec sauce Marinara) Net Wt. 340 g (12 Ounces) Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734153944458

This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory.
FDA Class I

Classic Deli Pasta Salad, 14 oz UPC 0 36406 30264 6

Product contaminated with Listeria monocytogenes
FDA Class II

Sprinkle King, Yellow Sanding Sugar,QYEL413.L32, UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 32 lb (14.51 kg).

Metal
FDA Class I

219772 509998 MARKET DISTRICT APRICOT LOG

All lots of Market District brand Apricot Logs and Poppyseed Logs prepared and sold individually from the Bakery department inside Giant Eagle and Market District supermarkets with sell by dates from November 7, 2015 through November 17, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen