2019 Product Recalls

6,140 recalls issued in 2019.

6,140

Total Recalls

131

USDA

241

CPSC

2,152

FDA Drug

USDA 131 CPSC 241 FDA Drug 2,152 FDA Device 738 NHTSA 1,015 FDA Food 1,863

Showing 1–20 of 6,140 recalls

NHTSA Dec 31, 2019

Brake Relay Valve Air Flow Restriction

An increase in stopping distance increases the risk of crash.

Toyne will notify owners, and dealers will inspect and replace the valves, as necessary, free of charge. The recall is expected to begin in January 2020. Owners may contact Toyne customer service at 1-712-673-2328.

FDA Dec 31, 2019

TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.

This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.

FDA Dec 31, 2019

Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.

Urgent Field Safety Notice notification letters dated 10/23/19 were sent to customers. Action to be taken by the customer/user: The user shall take note of amendment/reinforcement of Instructions for Use (IFU) and Service Manual, attached to this FN and, if it is the case, request a service technician to do the periodic preventive maintenance the user shall replace the attached pages in the User Manual and in the Service Manual, prescribing the periodic replacement of the angulation chain. Fill the table present in the addendum; In the cell "Next replacement date" write the date adding 8 years to the replacement date. All the examinations performed on the device before the recall remain valid. The IFU and the Service Manual need to be amended to prescribe the replacement of the angulation chain after 8 years of service life of the unit. This notice needs to be passed to all users of Apollo, Apollo DRF, Apollo EZ and to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.

FDA Dec 31, 2019

Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use on all surgical instruments, flexible endoscopes and probes.

The product is contaminated with Pseudomonas.

Cygnus sent an Urgent Medical Device Recall notification letters dated December 14, 2018 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 800-990-7489.

NHTSA Dec 30, 2019

Tag Axle May Become Misaligned

If the tag axle becomes misaligned with the front of the vehicle, the rear of the vehicle may strike other vehicles or pedestrians, increasing the risk of a crash or injury.

MCI will notify owners, and dealers will replace the block clamps and retorque the fasteners, free of charge. The recall began February 19, 2020. Owners may contact MCI customer service at 1-800-241-2947.

FDA Dec 30, 2019

The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.

The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).

The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit ( I mnW) established for Class 11 lasers. These products would be more appropriately categorized in Class Ilia (IFEC Laser Class 3R).

USDA Class I Dec 30, 2019

J&J Distributing Recalls Salad Products Due to Misbranding and Undeclared Allergens

Misbranding, Unreported Allergens

NHTSA Dec 27, 2019

Headlamp Relay May Disconnect from Fuse Box

Headlights failing can cause reduced visibility, increasing the risk of a crash.

Autocar will notify owners, and dealers will install a fuse box relay retainer, free of charge. Autocar issued owners an interim notification on February 24, 2020. The recall began August 27, 2020. Owners may contact Autocar customer service at 1-888-218-3611 or 1-877-973-3486. Autocar's number for this recall is ACTT-2002.

NHTSA Dec 27, 2019

Transmission Shift Pad May Fail/FMVSS 102

If the shift pad display fails, the operator will not know the transmission range or sequence information, increasing the risk of a crash or injury.

Autocar will notify owners, and dealers will relocate the shift pad, free of charge. Autocar issued owners an interim notification on February 24, 2020. Owners may contact Autocar customer service at 1-888-218-3611 or 1-877-973-3486. Autocar's number for this recall is ACTT-2001.

FDA Dec 26, 2019

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Urgent Medical Device Correction notification letters dated 9/16/19 were sent to customers. Necessary Actions Immediately discontinue use of the affected lots listed and switch to the alternate material lot(s) you may have available in your laboratory. Immediately destroy any remaining inventory of the affected lots listed according to your laboratory procedures. Complete and return the accompanying verification form Immediately order replacement material(s) if you do not have unaffected material available. Please retain this letter for your laboratory records.

FDA Class III Dec 25, 2019

VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

FDA Class I Dec 25, 2019

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

FDA Class III Dec 25, 2019

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA

Failed Dissolution Specifications: High out of specification result observed at stability studies.

FDA Class II Dec 25, 2019

Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..

FDA Class II Dec 25, 2019