Bosket Bread Company, LLC Recalls

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Sesame Buns (Bosket Bread) – Undeclared Allergens (2021)

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Brioche Dinner Rolls (Bosket Bread) – Undeclared Allergens (2021)

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Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Class IIModerate

FDADec 16, 2021IN, WA• Bosket Bread Company, LLC

8 Grain Bread (Bosket Bread) – Undeclared Allergens (2021)

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Ciabatta Loaves (Bosket Bread) – Undeclared Allergens (2021)

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

Country Loaf (Bosket Bread) – Undeclared Allergens (2021)

Undeclared Wheat, Milk, Egg, Soy, or Sesame on retail packaged bread products due to no ingredient statements.

FDADec 15, 2021Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Clobetasol Ointment (Taro) – Bacterial Contamination (2021)

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Class IHigh

Abiomed, Inc.: OXY-1 System, Model Number 001-0500-001. Used during card...

The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.

FDADec 14, 2021FL, GA, IN +4 more• Abiomed, Inc.

DELPHI AFTERMARKET TIE ROD Equipment Recall: STEERING:LINKAGES:TIE ROD ASSEMBLY

BorgWarner is recalling certain Delphi Aftermarket Tie Rod assemblies, part number TA5323, and size 319 mm. The inner tie rod assembly may have been manufactured incorrectly, which can allow the tie rod to detach from the steering rack.

NHTSADec 14, 2021Nationwide• DELPHI AFTERMARKET

Collagen Matrix, Inc.: DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inc...

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

FDADec 13, 2021Nationwide• Collagen Matrix, Inc.

Collagen Matrix, Inc.: RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as du...

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

FDADec 13, 2021Nationwide• Collagen Matrix, Inc.

Olympus Corporation of the Americas: OER-Elite Endoscope Reprocessor-for use in cleaning and h...

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

FDADec 13, 2021Nationwide• Olympus Corporation of the Americas

FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel: The EnPlace is a single use trans-vaginal pelvic floor re...

Certain lots may not have been packaged wth the Channel Tube Limiter.

FDADec 13, 2021Nationwide• FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel

Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.

FDADec 10, 2021Nationwide• Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin

Greiner Bio-One North America, Inc.: greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Se...

Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

FDADec 9, 2021FL, IL, MO +7 more• Greiner Bio-One North America, Inc.

Howling Cow Butter Almond Ice Cream – Mislabeled Ingredients (2021)

The firm was notified by a customer that the Butter Almond containers contains Cookie Dough Ice Cream. The Cookie Dough Ice Cream contains soy and wheat which are not listed on the label for the Butter Almond Ice Cream.

Class IHigh

FDADec 9, 2021IN, NC, SC• Maryland & Virginia Milk Producers

Children's Robes (Mark of Fifth Avenue) – Flammability Violation (2021)

Fire/Burn Risk

This recall involves Star Art in Linen-branded children's 100% polyester robes. The robes were sold in six children's sizes 2, 3-4, 5-6, 6-7, 7-8, and 10-12 in the following seven colors: black, navy, blue plaid, red plaid, red, royal blue, and gray. The long-sleeved robes have two front pockets and two side seam belt loops with a matching belt. "Made in China" and "100% Polyester" are printed on a sewn-in label in the robes seam.

CPSCDec 8, 2021Nationwide• Mark of Fifth Avenue, of Harriman, N.Y.

Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands: Disposable Subdermal Needle Electrode, Corkscrew, Single ...

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

FDADec 8, 2021Nationwide• Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands

Happi Foodi Roasted Russets (Prepared Meals) – Mold Contamination (2021)

Presence of visible mold detected.

Class IIILow

FDADec 8, 2021CA• Prepared Meals Co

Brinzolamide Suspension (Teva) – Defective Container (2021)

Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.