2013 Product Recalls

5,512 recalls issued in 2013.

5,512
Total Recalls
290
CPSC
1,377
FDA Drug
1,026
FDA Device
CPSC 290 FDA Drug 1,377 FDA Device 1,026 NHTSA 708 FDA Food 2,111

Showing 21–40 of 5,512 recalls

NHTSA

Aftermarket Tail Lamps (Circuits Switched)

The reversed tail lamp function reduces the ability to warn other motorists of the driver's intentions, increasing the risk of a crash.

Genera will notify owners and provide replacement aftermarket tail lamps, free of charge. The recall began on January 23, 2014. Owners may contact Genera at 1-888-963-9888. This recall is being conducted by Genera Corporation, not by Toyota Motor Corporation.
NHTSA

Parking Brake may Unexpectedly Release

If the park brake pedal arm fractures, the bus may unexpectedly roll increasing the risk of personal injury or a vehicle crash.

Blue Bird has notified owners and dealers will install a new parking brake assembly, free of charge. The recall began on December 31, 2013. Owners may contact Blue Bird at 1-478-822-2242. Blue Bird's number for this recall is R13WT.
NHTSA

Battery Equalizers/DC-DC Converters-Possible Fire

Once electrically conductive, the material is capable of melting and burning, increasing the risk of a fire.

Nova Bus will notify owners and dealers will inspect and replace the converters, as necessary, free of charge. The recall is expected to begin in January 2014. Owners may contact Nova Bus at 1-450-472-6410. Nova Bus's numbers for this recall are CR3030, CR3031, CR3032, CR3033 and CR3034 (depending on the converter's part number and location of in the vehicle).
NHTSA

Automatic Over-Speed Protection System

Without a system to control the engine speed, if airborne hydrocarbons (combustible vapors) enter through the air intake, excessive engine speed may result in a catastrophic engine failure and/or engine fire.

Mack will notify owners, and dealers will correct the system wiring, free of charge. The recall began on February 20, 2014. Owners may contact Mack Trucks at 1-336-393-2000. Mack's number for this recall is SC0374.
NHTSA

Speedometer may Read Lower than Actual Speed

With the incorrect calibration, the driver may unknowingly exceed the posted speed limit, increasing the risk of a crash.

DTNA will notify owners, and dealers will update the instrument cluster software to the correct calibration, free of charge. Owners may contact DTNA at 1-800-547-0712. DTNA's number for this recall is FL-658.
FDA

Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme i

Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution.

Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center Via our website, http://www.beckmancoulter.com/customersupport/support Via phone, call 1-800-854-3633 in the United States Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.
FDA

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.

CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

CareFusion sent an Urgent Medical Device Recall Notification letter dated August 30, 2013, to all affected customers to inform them that CareFusion is recalling the Gravity Set, Model 44000-07, Lot Numbers 12086930, 12106215, 13016408, 13016834, 13025446 and 13025672 as a result of an incorrect expiration date. The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and if they have questions then they are instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.
FDA

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with

The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

OrthoPediatrics sent an Urgent Medical Device Recall letter dated September 26, 2013, to all affected customers.The letter identified the product the problem and the actions needed to be taken by the customer The sales representatives and distributors who have been identified via shipping records as having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on 18-September-2013. If you or any of your customers have any of these devices in the original packaging please take possession of them and quarantine them in preparation for returning them to OrthoPedlatrics. They are misbranded. If the Screw has already been removed from the original packaging and the original packaging has been discarded and the Screw placed in a sterilization tray, it need not be returned. For further questions please call ( 574) 268-6379.
FDA

Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.

Philips Healthcare sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. This Field Safety notification is to inform the actions that should be taken by the customer/user to prevent risks for patient or users, and the actions planned by Philips to correct the problem. If you need further information or supplies please contact your local Philips Healthcare office. For North American and Canada contact the Customer Care Solutions Center ( 1-800 722-9377) option 5 enter site or follow the prompts.
FDA Class II

UT-Fem¿ FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc.

The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients. Subsequent private laboratory testing of the finished product revealed levels of chloramphenicol above 0.3 ppb.
FDA Class I

Garden-Fresh, Seafood Salad Rouille, 1/5 lb., 0 11596 55187 6, 12/6/2013;

Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
FDA Class I

Garden-Fresh, Red Cabbage Shredded, 1/5 lb., 0 11596 50590, Manufactured on 10/28/2013 - 11/6/2013; Garden-Fresh, Red Cabbage Shredded 4/5 lb., 0 11596 50592 3, 10/28/2013 - 11/6/2013;

Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
FDA Class II

Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
FDA Class I

Garden-Fresh, Sweet & Sour Cucumber, 2/5 lb., 0 11596 52014 8, 11/15/2013 - 11/30/2013;

Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
FDA Class I

Grandpa's ,Red Skin Potato Salad, 2/5 lb., 0 11596 51080 4, 11/22/2013 - 12/10/2013; Grandpa's, Red Skin Potato Salad, 12/16 oz,. 0 11596 14061 2, 0 11596 24061 9, 11/25/2013 - 12/10/2013;

Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
FDA Class I

Copperwood Kitchens, Steakhouse Macaroni Salad, 2/5 lb., 8 11839 01018 0, 12/5/2013

Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
FDA Class II

Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
FDA Class II

Dietary Supplements packaged in the following configurations: (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274); (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426);

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
FDA Class II

Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
FDA Class II

Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA; (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC; (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottle

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol