The Santa Barbara Smokehouse, Inc. Recalls

The firm is recalling batches of smoked salmon due to environmental and finished product samples found positive for Listeria monocytogenes.

FDADec 26, 2014AZ, CA, CO +14 more• The Santa Barbara Smokehouse, Inc.

Wild Pacific Salmon (Santa Barbara) – Listeria Risk (2014)

The firm is recalling batches of smoked salmon due to environmental and finished product samples found positive for Listeria monocytogenes.

FDADec 26, 2014AZ, CA, CO +14 more• The Santa Barbara Smokehouse, Inc.

Smoked Atlantic Salmon (Santa Barbara Smokehouse) – Listeria Risk (2014)

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Listeria

The firm is recalling batches of smoked salmon due to environmental and finished product samples found positive for Listeria monocytogenes.

Class IHigh

FDADec 26, 2014AZ, CA, CO +14 more• The Santa Barbara Smokehouse, Inc.

Whiskey Smoked Salmon (Santa Barbara) – Listeria Risk (2014)

The firm is recalling batches of smoked salmon due to environmental and finished product samples found positive for Listeria monocytogenes.

FDADec 26, 2014AZ, CA, CO +14 more• The Santa Barbara Smokehouse, Inc.

Beechwood Smoked Salmon (Santa Barbara Smokehouse) – Listeria Risk (2014)

The firm is recalling batches of smoked salmon due to environmental and finished product samples found positive for Listeria monocytogenes.

FDADec 26, 2014AZ, CA, CO +14 more• The Santa Barbara Smokehouse, Inc.

Circuit Breakers (Schneider Electric) – electrical safety (2014)

Fire/Burn Risk

The recall involves PowerPact J-frame molded case circuit breakers with thermal-magnetic trip units. The circuit breakers are made of black plastic and have a three-position breaker handle that indicates whether the breaker is off, on or tripped. The recalled circuit breakers are rated for 150 to 250 amps, have interruption ratings of D, G, J, L and R. They were manufactured in two pole and three pole configurations with either lug-in/lug-out or plug-in (I-Line) style connectors. Brand name "Schneider Electric" or "Square D" is on a yellow sticker above the breaker handle and on the top of a label on the side of the circuit breaker. A label on the front of the circuit breaker to the left of the breaker handle has the catalog number at the top. The number also appears on a label on the side of the breaker. Schneider Electric catalog numbers begin with "NJ" and Square D catalog numbers begin with "J." A label on the front of the circuit breaker to the right of the breaker handle has the date code in the lower right corner. Recalled circuit breakers were manufactured from March 26, 2014 through September 26, 2014 and have date codes 14131 through 14395. The date codes are in the YYWWD format (example: 14131 = year 2014, week 13, day of the work week 1/ Monday). Breakers with following catalog numbers are being recalled: Catalog Number Breaker Type (N)JDX26XXX 2 Pole (N)JGX26XXX 2 Pole (N)JJX26XXX 2 Pole (N)JLX26XXX 2 Pole (N)JDX36XXX 3 Pole (N)JGX36XXX 3 Pole (N)JJX36XXX 3 Pole (N)JLX36XXX 3 Pole (N)JRX36XXX 3 Pole

CPSCDec 18, 2014Nationwide• Schneider Electric USA Inc., of Columbia, Mo., and Tlaxcala, Mexico

Entertainer's Secret Throat Relief (Tropichem) - microbial contamination (2014)

E. coli

Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli

FDADec 17, 2014IN, NY• Tropichem Research Labs, Inc.

Orthovita, Inc., dBA Stryker Orthobiologics.: Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement ...

There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.

FDADec 4, 2014Nationwide• Orthovita, Inc., dBA Stryker Orthobiologics.

Orthovita, Inc., dBA Stryker Orthobiologics.: Stryker Orthobiologics Imbibe Bone Marrow Aspiration Need...

There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.

FDADec 4, 2014Nationwide• Orthovita, Inc., dBA Stryker Orthobiologics.

Arjo Hospital Equipment AB: RotoRest Delta Advanced Therapy System. The RotoRest D...

The recalled devices labeling and instructions for use contain unapproved medical claims.

FDADec 3, 2014Nationwide• Arjo Hospital Equipment AB

Arjo Hospital Equipment AB: Rotoprone Therapy System. The Rotoprone Therapy System...

The recalled devices labeling and instructions for use contain unapproved medical claims.

FDADec 3, 2014Nationwide• Arjo Hospital Equipment AB

Arjo Hospital Equipment AB: TriaDyne Proventa Critical Care Therapy System. The Tr...

The recalled devices labeling and instructions for use contain unapproved medical claims.

FDADec 3, 2014Nationwide• Arjo Hospital Equipment AB

Balmoral Smoked Salmon (Santa Barbara Smokehouse) – Listeria Contamination (2014)

The firm was notified by two customers of two lot/batch numbers testing positive for Listeria monocytogenes which is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal

FDANov 28, 2014AZ, CA, IL +4 more• The Santa Barbara Smokehouse, Inc.

Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA Reagent Container, Model No. B1037307 (15 mL),...

HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes

FDANov 13, 2014Nationwide• Horiba Instruments, Inc dba Horiba Medical

Everything Bagels (Schwartz Brothers) – mislabeled milk (2014)

Mislabeling. Product inside a plastic bag actually contains milk but mis-labeled as "Everything Bagels" and this label does not declare milk.

FDANov 6, 2014IN, OR, WA• Schwartz Brothers Restaurants dba Schwartz Brothers Bakery

Roche Diabetes Care, Inc.: ACCU-CHEK Connect Diabetes Management App; Instruction Ma...

Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb

FDAOct 30, 2014IN• Roche Diabetes Care, Inc.

Mercaptopurine Tablets (Prometheus Labs) – dissolution failure (2014)

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

FDAOct 22, 2014Nationwide• Prometheus Laboratories Inc.

INO Therapeutics (dba Ikaria): INOMAX DSIR Nitric Oxide delivery system, Model 10007, so...

An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.

FDAOct 17, 2014IN, PA, VA• INO Therapeutics (dba Ikaria)

Super Plant Protein (Herb Garden) – Salmonella Potential (2014)

Salmonella

Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.

FDAOct 14, 2014NV• Herb Garden Productions

Green Formula (Herb Garden) – Salmonella Potential (2014)

Salmonella

Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.