2015 Product Recalls
7,426 recalls issued in 2015.
Showing 1–20 of 7,426 recalls
Water Heater May Scald Operator
The overheating of the water may result in the release of steam, possibly causing the operator is to scald themselves and increasing the risk of injury.
Compass Conversions will notify the owners and Atwood dealers will install a remedy kit, free of charge. The recall began on January 10, 2016. Owners may contact Compass Conversion customer service at 1-254-771-9909 or Atwood customer service at 1-574-264-2131.
Incorrect Load Range/FMVSS 120
If the truck exceeds the load rating on the tire, the tire may suddenly fail, increasing the risk of a crash.
Peterbilt will notify owners, and dealers will replace the 8.25" front wheels with 9.00" wheels and re-program the maximum vehicle speed to the appropriate settings, free of charge. The recall began on January 14, 2016. Owners may contact Peterbilt customer service at 1-940-591-4000. PACCAR's recall campaign number for this recall is 1115Q.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
TRUMPF sent an " Urgent Field Safety Information" letter dated December 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the customer: 1. Perform an inspection of the lighting systems (see Appendix 1 for instructions). If any of the symptoms listed below are observed, immediately remove the light from operation and contact your Trumpf Medical Service Representative or designee. Signs that indicate a possible fall of the spring arm: The movement of the light and spring arm is difficult for the user, The lights have stopped being operational, and/or A gap is noticed between the spring arm and the central axis (see the attached Appendix 1 for an example). 2. Follow the User Manual: No unauthorized servicing of the spring arm is permitted. Snap rings are one use only and replacements must be purchased from your authorized Trumpf Medical partner. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359
Du Monde Gourmet Recalls Jafflz Sandwich Products Due To Possible Cooling/Process Deviation
Processing Defect
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.
Drain Hole Orientation in Front Brake Chamber
Corrosion, part deterioration, or frozen water in the brake chamber may reduce braking ability, increasing the risk of a crash.
Gillig will notify owners and the brake chambers will be replaced free of charge. The recall began on March 1, 2016. Owners may contact Gillig customer service at 1-800-735-1500.
Steering Gearbox Malfunction
A gearbox malfunction may cause a loss of vehicle control and increase the risk of a crash.
BMW will replace the steering gearbox, free of charge. Affected vehicles are located in dealer inventory and will be remedied before customer retail. The recall began on December 28, 2015. Owners may contact BMW customer service at 1-800-525-7417.
STOP Arm Decals may Peel Off/FMVSS 131
Absence of the reflective decal would reduce visibility to other drivers, increasing the risk of a crash.
Micro Bird will notify owners and recall repair kits will be available free of charge. The recall began on January 20, 2016. Owners may contact Micro Bird customer service at 1-819-477-2012.
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
Origin8 folding bicycles Recalled for Fall Hazard
The frame on the folding bicycles can break, posing a fall hazard.
Consumers should stop using the recalled bicycles immediately and return them to the place where purchased for a free replacement bicycle.
KTM Competition/Closed Course Off-Road Motorcycles Recalled for Fire Hazard
Under extreme riding conditions, fuel can escape from the tank breather assembly. This poses a risk of fire and injury to the rider.
Consumers should immediately stop riding the recalled motorcycles and contact an authorized KTM dealer to schedule a free repair. KTM is contacting consumers who purchased the recalled product directly.
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.
Spacelabs began to send the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter, dated 28, January 2015, to US consignees. Spacelabs began sending the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter (translated as necessary) to international customers via email on 2/4/15. Actions to be Implemented by Users: -Do not rely solely on the monitor for critically ill patients. -If customer facility operates any XPREZZON or qube monitors on a standalone basis, rather than via central monitoring, please contact Spacelabs technical support as these monitors will be the first repaired. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to replace the PCBAs in all of your facility's affected XPREZZON and qube monitors at no cost. If you have any questions about this corrective action, please contact Spacelabs at the toll free number of 1-800-522-7025 and select 2 for Technical Support, or via direct dial at 1-425-363-5203.
HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, d
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Basma 3 Chris Court Dayton, New Jersey 08810 Tel.:7323559600 Fax: 7323559644 16 oz package This golden raisin product is labeled in a foreign language.
Product contains undeclared sulfites.
Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g.
Possible Listeria monocytogenes contamination.
TRC Golden Medium Raisins Packed by: The Raisin Company (PTY) LTD FActory AT: Noagspaal, Marchand, South Africa PO BOx 77, Marchand 8873 Produce of South Africa
Product contains undeclared sulfites.
Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product.
The processed herring was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.