January 2015 recalls

327 recalls were announced in January 2015.

What the numbers show

Critical: 23
Severe: 124
High: 114
Moderate: 53
Low: 13

Of the 327 recalls this month scored against our rubric, 7% are Critical, 38% are Severe.

Which agencies issued them

301–327 of 327

SevereFDA (Drugs)·D-0328-2015·2015-01-07
Tropichem Recalls Entertainer's Secret Throat Relief Due to E. Coli Contamination
Tropichem Research Labs is recalling Entertainer's Secret Throat Relief due to microbial contamination, including E. Coli. The product was distributed in New York and Indiana.
Product
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
Category
Drug
Distribution
2 states
SevereFDA (Devices)·Z-0896-2015·2015-01-07
Hansen Medical Recalls Sensei X Robotic Catheter Systems Due to Loose Clamp
Hansen Medical is recalling Sensei X Robotic Catheter Systems because a mechanical clamp may become loose, causing the device to fall and potentially injure patients or users.
Product
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0876-2015·2015-01-07
Bard Caliber Inflation Device Recalled for Pressure Limitations
Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.
Product
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2015·2015-01-07
ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2015·2015-01-07
Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles
Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.
Product
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0884-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2015·2015-01-07
ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0898-2015·2015-01-07
Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure
Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.
Product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0901-2015·2015-01-07
Nonin Medical Recalls Regional Oximetry Sensors Due to Signal Loss
Nonin Medical is recalling specific regional oximetry sensors because they may lose signal when used on diaphoretic patients. No injuries or illnesses have been reported.
Product
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed i
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0895-2015·2015-01-07
Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise
Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.
Product
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0762-2015·2015-01-07
King & Prince Seafood Recalls BREADED OYSTERS Due to Norovirus
King & Prince Seafood is recalling MRS FRIDAY'S GOURMET BREADED MEDIUM OYSTERS because the product tested positive for Norovirus GI GII.
Product
MRS FRIDAY'S GOURMET BREADED MEDIUM OYSTERS 18/25 CT/LB, Net Wt. 2.5 lbs (1.13 kg), Ready to Fry, Distributed by: King and Prince Seafood Corporation, Brunswick, GA 31621
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0887-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment
Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2015·2015-01-07
ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment
Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling 13,041 boxes of ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2015·2015-01-07
Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure
Smiths Medical ASD, Inc. is recalling 10,000 units of Needle Pro Edge Safety Hypodermic Needles because the needle may not be captured in the safety sheath.
Product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2015·2015-01-07
Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk
Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.
Product
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2015·2015-01-07
Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error
Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected units were distributed internationally.
Product
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0877-2015·2015-01-07
Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations
Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.
Product
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to def
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0327-2015·2015-01-07
Jaymac Pharmaceuticals Recalls J-TAN D PD Drops Due to Dye Labeling Error
Jaymac Pharmaceuticals is recalling J-TAN D PD Drops because the product is labeled 'Dye Free' but contains Red Dye 40.
Product
J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30.
Category
Drug
Distribution
4 states
ModerateFDA (Devices)·Z-0879-2015·2015-01-07
Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error
Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.
Product
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0900-2015·2015-01-07
Zimmer Recalls Osteobond Bone Cement Due to Adhesive Transfer Defect
Zimmer, Inc. is recalling 40 units of Osteobond Bone Cement because samples failed to meet visual requirements for adhesive transfer between the Tyvek lid and cavity.
Product
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Category
Medical Device
Distribution
3 states
HighNHTSA·15V001000·2015-01-05
MCI Recalls J4500 Motor Coaches Due to Brake Hose Wear Risk
Motor Coach Industries is recalling 2013-2015 MCI J4500 motor coaches because a brake hose may rub against the tire or control arm, potentially causing a loss of braking power.
Product
MCI — MCI J4500
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·001-2015·2015-01-02
Texas Firm Recalls Australian Lamb Products Imported Without Inspection
AMD Imports Inc. is recalling approximately 35,275 pounds of Australian lamb products because they were not presented for USDA inspection at the U.S. point of entry.
Product
Texas Firm Recalls Lamb Products Imported Without Benefit of Inspection
Category
Food
Distribution
1 state

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