FDA Recalls in 2020

3,691 recalls found

January 2020

FDA

GIZA Vertebral Body Replacement

Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

A correction letter to the users was sent on March 28, 2017 Stating the following: Eden Spine Europe has become aware of extremely rare incidents of disassembly of Giza devices, which is distributed by Stryker Spine in the USA. These incidents have occurred in limited situations when a surgeon has needed to unscrew the device in order to readjust the distraction. To mitigate this risk, a more precise description of the unlocking procedure in the Giza Surgical Technique was added to prevent surgeons from fully unscrewing the locking screw. POTENTIAL HAZARD In the unlikely event the Giza device was to disassemble, the potential hazard is that the surgeon may decide either to reassemble the device or change the implant to a new device. This could potentially lead to a short surgical time delay of 2 to 10 minutes. RISK MITIGATIONS Eden Spine Europe and Stryker have added the following information in the Giza Surgical Technique to mitigate the risk of disassembly of the device: Note: If adjustment is needed, the implant locking mechanism must be unscrewed 3.5 to 4 rotations from the tightened position, to free the superior cylinder from the inferior one. No more than 4 counterclockwise rotations should be applied to the locking screw, as doing so could potentially lead to disassembly of the implant's locking mechanism. The GIZATM Vertebral Body Replacement surgical technique is available on Stryke Spine's website. ACKNOWLEDGEMENT OF THIS NOTICE Please acknowledge within 5 days of receipt of this notice: - Fill out and send the following online for: https://fr.surveymonkey.com/r/5XYT3ZQ - Or Send an Email to the following address: Customer.service@edenspine.com stating that this notice was received. For any questions you may contact: Christophe Zuanon, Regulatory Affairs & Quality Assurance Manager c.zuanon@edenspine.com Manager, c.zuanon@edenspine.com
FDA

Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

May result in elevated platelet backgrounds during routine startup/background checks.

The firm sent notification of recall to consignees on 04/21/2017 by mail in domestic states, and by email or mail to foreign consignees. The notification informed consignees of the product removal. it instructed consignees to discontinue use, destroy product on hand, complete the product destruction form, and contact the firm's customer service department (305-324-2300 or 800-433-0945) to request product replacement.
FDA

ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.

An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 29, 2016 to be delivered to customers on August 1, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 28, 2016. These emphasize that the prostate specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.g., the 2013 American Urological Association (AUA) Guidelines or the 2015 European Association of Urology (EAU)). These guidelines define biochemical recurrence of prostate cancer as a detectable or rising PSA value post-radical prostatectomy that is > or = 0.2 ng/mL (ug/L) with a second confirmatory level of > or = 0.2 ng/mL (ug/L). The communications also provide functional sensitivity from a recent study to give an expectation of precision at the low end of the assay.
FDA

NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Subpotent Drug
FDA

NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Subpotent Drug
FDA

Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.

Subpotent Drug: Supplier indicated assay results did not meet specifications.
FDA

NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.

Subpotent Drug
FDA

Trader Joe's 8pc Tempura Shrimp Crunch Roll, 8.5oz, SKU 513289

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Suantianyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407226 and 3.12.2020 stamped on the box

Products contain undeclared sulfites and cyclamates.
FDA

Okami brand 8pc Supreme Sampler, SKU 28112

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's 8pcs Regular California Roll, 8oz, SKU 00348997T

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's 10oz Banh Mi Style Salad w/ Tofu, SKU 614719

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's Shrimp Spring Rolls 7oz, SKU 908795

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.

Wild Harvest Organic Unbleached All Purpose Flour in 5 lb. bags has the potential to be contaminated with E. coli (STEC).
FDA

White Castle Sliders - Jalapeno Cheese Sliders - Jalapeno Cheeseburgers, UPC 8298801106 (6pk Jalapeno Cheeseburger)

Products recalled due to possible contamination with Listeria monocytogenes
FDA

Trader Joe's 8pcs Spicy California Roll, 8oz, SKU 00348966T

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's 8pcs Smoked Salmon Philly Roll, SKU 603775

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's 8pcs Brown Rice California Roll, 8oz, SKU 909822

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's 8.4oz Smoked Salmon Poke Bowl, SKU 603751

RTE products potentially contaminated with Listeria monocytogenes.
FDA

R.H. Macys & Co. Cinnamon Roasted Almonds, in 10oz metal tin, UPC 788709600317

Incorrect product label on back panel
FDA

Frozen Yellowfin Tuna Steak, 4 oz. and 6 oz., Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328

Products have the potential to cause scombrotoxin fish poisoning because they may have increased levels of histamine.
FDA

Trader Joes Queso Fundido 16oz, SKU 646574

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc Salmon Philly Roll, SKU 28113

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 25pcs Sushi Platter, SKU 28200

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc Spicy California Roll, SKU 28102

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami 8pc SEAFOOD COMBO 6 SURIMI 2 EBI SHRIMP, SKU 28262

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc California Roll, SKU 28101

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc Supreme Combo, SKU 28111

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc Supreme California Roll, SKU 28103

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 8pc Supreme California Roll, SKU 28103

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Trader Joe's Tofu Spring Rolls 7oz, SKU 921510

RTE products potentially contaminated with Listeria monocytogenes.
FDA

White Castle Sliders - The Original Slider Hamburgers

Products recalled due to possible contamination with Listeria monocytogenes
FDA

Bingtangyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407219 and date 02.13.2020 stamped on the box

Products contain undeclared sulfites and cyclamates.
FDA

Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328

Products have the potential to cause scombrotoxin fish poisoning because they may have increased levels of histamine.
FDA

Frozen Yellowfin Tuna Ground Meat, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328

Products have the potential to cause scombrotoxin fish poisoning because they may have increased levels of histamine.
FDA

Okami brand 8pc Spicy Supreme California Roll, SKU 28104

RTE products potentially contaminated with Listeria monocytogenes.
FDA

Okami brand 16pcs Sushi Platter, SKU 28201

RTE products potentially contaminated with Listeria monocytogenes.
FDA

White Castle Sliders - Cheese Sliders - Cheeseburgers UPC 8298801006 (6pk Cheeseburger), UPC 829880116 (16pk Cheeseburger)

Products recalled due to possible contamination with Listeria monocytogenes
FDA

Okami OK Tempura Shrimp Roll, 6pc w/ Sweet and Dynamite Sauce, SKU 28114

RTE products potentially contaminated with Listeria monocytogenes.
FDA

R.H. Macys & Co. Roasted Salted Cherries Berries and Nuts with Dark Chocolate, in 10oz metal tin, UPC - 788709600362

Incorrect product label on back panel, undeclared cashew, pecan, milk and soy
FDA

Okami brand 8pc Brown Rice Classic California Roll, SKU 28122

RTE products potentially contaminated with Listeria monocytogenes.