Rise Baking Company dba South Coast Baking Recalls

FDAMay 2, 2024CA, CO, FL +18 more• Rise Baking Company dba South Coast Baking

Panera Oatmeal Raisin Cookie (Rise Baking) – Salmonella Contamination (2024)

Salmonella

Potential Salmonella contamination

FDAMay 2, 2024CA, CO, FL +18 more• Rise Baking Company dba South Coast Baking

D*Clot HD Thrombectomy System (Mermaid Medical) – Bubble Leak (2024)

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

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Moderate

FDAMay 1, 2024Nationwide• Mermaid Medical A/S Frydensbergvej 25 Stenlose Denmark

Fentanyl Injection (Hikma) – Incorrect Barcode (2024)

Labeling: Wrong Barcode

Class IIILow

FDAApr 30, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – Label Mix-up (2024)

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

FDAApr 29, 2024CO, GA, PA +2 more• Hikma Injectables USA Inc

Micro Bird G5 School Bus – Power Steering Line (2024)

Corp. Mirco Bird, Inc. (Micro Bird) is recalling certain 2019-2022 G5 school buses. An inadequate connection between the power steering pressure line and the brake hydroboost unit may result in a sudden loss of power steering fluid.

NHTSAApr 26, 2024Nationwide• MICRO BIRD

Mercedes Benz ML550 (Mercedes Benz) – Brake System (2024)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2006-2012 ML, GL, and R-Class vehicles. Please refer to MBUSA's recall report for specific vehicle model details. Moisture may accumulate and cause corrosion in the brake booster housing unit, which can result in reduced brake performance or brake failure.

NHTSAApr 26, 2024Nationwide• MERCEDES BENZ

MNA-420 ENC HDMI (Barco) – SFP+ Module Issue (2024)

We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.

Low

FDAApr 24, 2024FL• Barco N.V. President Kennedypark 35 Kortrijk Belgium

Progesterone Tablets (Anazao) – Metal Fragment (2024)

Presence of Foreign Substance; Broken metal piece found embedded in tablet.

FDAApr 24, 2024Nationwide• Coast Quality Pharmacy, LLC dba Anazao Health

Tirzepatide (Revive Rx) – Labeling Mix-up (2024)

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

FDAApr 20, 2024Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

Mi1250 SYNCHRONY 2 (MED-EL) – internal electronics crack (2024)

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

Moderate

FDAApr 18, 2024NC• MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria

Tiramisu Dessert (Mama Mucci's) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk and incomplete Contains statement

FDAApr 18, 2024MI• Mucci Food Products, Ltd. DBA Mama Mucci's Pasta

Goat Milk Toddler Formula (Sammy's Milk) – Marketing Issue (2024)

FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.

FDAApr 18, 2024AL, AK, AZ +40 more• Graceleigh, Inc. dba Sammy's Milk

Goat Milk Toddler Formula (Sammy's Milk) – Marketing Issue (2024)

FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for use as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.

FDAApr 18, 2024AL, AK, AZ +40 more• Graceleigh, Inc. dba Sammy's Milk

Gordofilm Wart Remover (Gordon Laboratories) – Manufacturing Deviation (2024)

cGMP Deviations

FDAApr 12, 2024Nationwide• Dercher Enterprises, Inc., DBA Gordon Laboratories

Quilts and Shams (Red Land Cotton) – Laceration Risk (2024)

Laceration Risk

This recall involves Red Land Cotton quilts and quilted shams. The Classic quilts come in white, natural, ticking stripe, blue, or gray, in all sizes: twin, full/queen, and king/California king sizes. The Classic quilted euro shams come in white, natural and ticking stripe. King and Standard shams are white, natural, blue, gray and ticking stripe. Baby quilts come in white, natural and charcoal ticking print.

CPSCApr 11, 2024Nationwide• Red Land Cotton, Moulton, Alabama

RC4 Junior Ski Boots (Fischer Sports) – Fall Hazard (2024)

This recall involves RC4 50, RC4 60, and RC4 65 Junior Ski Boots in sizes 21.5 to 27.5. The RC4 50 and RC4 60 were sold in Rhino Grey and Snow colors. The RC4 65 was sold in yellow. "Fischer" is printed on the lower shell on each boot, and the specific model and name is printed on the outside of the upper cuff, between the two top buckles. The size of the boot is stamped on the sole.