FDA Recalls in 2019

4,753 recalls found

December 2019

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.

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).

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 Recalls in 2019

December 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.

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

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.

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.

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.

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

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

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

Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA

STIR FRY BEEF VEGAN served on the hot bar

Beef Broccoli Szechuan sold on the hot bar

VEGETABLE KORMA INDIAN served on the hot bar

Caulilini, Grilled with Sweet Poppy Seed Sauce sold in the chef's case and hot bar UPC 27268400000

BROCCOLI FLORETS CV BROCCOLI STEAMED and served on the salad bar

Pasta Turkey Alfredo sold on the hot bar

Caulilini, Roasted with Roasted Garlic served on the salad bar

BROCCOLI ROASTED BUFFALO served on the salad bar

GOURMET BAY Haddock with Seafood Stuffing; 6oz; SELL BY 05/26/21; LOT# 100457657; KEEP FROZEN; Cooking Instructions: Oven: Preheat oven to 400 degrees F. Place fish on a lined non-stick baking sheet. Bake for 15-20 minutes or until internal temperature reaches 165 degrees F.

Bowl, Korean Chicken UPC 26235400000 sold packaged in stores

Chicken Orange and Chick'n Orange Sauce sold on the hot bar and in the chef's case

Salmon Dinner with Thai Curry for 2 Packaged in the store UPC 20451500000

CAULIFLOWER BROCCOLI ROMESCO BASQUE served on the hot bar

Caulilini, Roasted Grape & Curry Vinaigrette Cindy's served on the salad bar

Beef & Broccoli sold on the hot bar

Beef Hoison Glazed sold on the hot bar

Truly Good Foods SOUTH OF THE BORDER nut mix NET CT/WT: 25lb box, CONTAINS: PEANUTS, MILK, AND WHEAT. Distributed by Truly Good Foods, Charlotte, N.C. 28273 UPC 0 94184 11019 8

Crab Rangoon 1.0 oz.

GARBANZO BROCCOLI FARRO served on the hot bar

Salmon Dinner with Mild Italian for 2 packaged in the store UPC 20451300000

SINGLE MEAL SALMON DETOX SALAD PALEO available in the chef's case UPC 23238900000

Tri-Color Coleslaw - Marketside brand; 16 oz. plastic bag, SKU 3117 Colorful Coleslaw/Salade de Chou - President's Choice Brand - (Canada only) 14 oz. plastic bag, SKU 3237 A blend of green and red cabbage and carrots. Marketside UPC: 6-81131-38748-4 President's Choice UPC: 0-60383222670

Broccoli and Cauliflower Chorizo Roasted sold on the hot bar and in chef's case

TOFU SALAD SWEET CHILE served on the salad bar

SALAD BROCCOLI CRUNCH served on the hot bar, salad bar, and chef's case UPC 24531600000 and UPC 24532000000

Salad Bar, Trend Alert Pickled Pear & Brussels Sprouts served on the salad bar

BROCCOLI ROASTED PALEO served on the salad bar

Family Meal Chicken Orange and Vegetable UPC 22849900000 sold packaged in stores, PLU 28499

PIZZA PESTO GREEN VEGGIE served on the salad bar

Vegetable Power Blend served on the salad bar

PLATTER CRUDITE VEGETABLE FOR 10 CA UPC 111686, 28587400000 and PLATTER CRUDITE VEGETABLE FOR 20 CA UPC 111687, 28587500000 available trough catering and packaged in stores

GOURMET BAY Flounder with Crabmeat Stuffing; SELL BY: 12/11/19; KEEP REFRIGERATED; Cooking Instructions: Oven: preheat oven to 400 degrees F. Place fish on a lined or non-stick baking sheet. Bake for 20-25 minutes or until internal temperature reaches 165 degrees F.

Caulilini & Broccoli Lemon Caper served on the salad bar

Beef Broccoli Spicy Paleo sold on the hot bar

SLAW BROCCOLI and served on the salad bar

BROCCOLI CHARRED ROMESCO served on the hot bar

Bowl, Shaved Brussel Sprout Grilled Chicken UPC 27332900000 sold packaged in stores

Salad Bar, Brussels Sprouts Shredded served on the salad bar