Search Product Recalls

INFINITI Vision System (Alcon) – Tubing Debris Concern (2014)

Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the aspiration line.

ACCU-CHEK Connect App (Roche) – Bolus Adjustment Risk (2014)

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

DIRECTVIEW CR Software (Carestream) – Mammography Printing Problem (2014)

Reduced mammographic image quality when attempting to print true size multi-format images

Heparin Sodium Injection (Baxter Healthcare) – low potency (2014)

Subpotent Drug: Heparin raw material was found to have low potency

Mrs Friday's Breaded Oysters (King & Prince) – Norovirus (2014)

Product tested positive for Norovirus GI GII

Titanium Cannulated Trochanteric Nail (Synthes) – Incorrect Assembly (2014)

The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.

Kosher Dill Chips (Mt. Olive) – glass fragment risk (2014)

Product may contain glass fragments.

Esprit V1000 Ventilator (Respironics) – Power Supply Defect (2014)

If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.

Crea A and B Membranes (Radiometer) – Quality Control Drift (2014)

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Remel TB Potassium Permanganate (Remel) – Performance Inconsistency (2014)

The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.

J700 Floor Mounted Tube Stand (Summit) – Weld Integrity Issue (2014)

The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.

Soft Contact Lens (Cooper Vision) – Lens Axis Condition (2014)

Portions of the lots may contain units with an incorrect lens axis condition.

Mammomat Inspiration System (Siemens) – Installation Safety (2014)

It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.

Monastery Washed Rind Cheese (Saxon Cheese) – E. coli contamination (2014)

Saxon Cheese LLC is recalling one lot of GreenFields Monastery Washed Rind Wisconsin handcrafted Cheese because product tested positive for E.coli.

Chicken Broth Base (Kent Precision Foods) – mislabeling (2014)

Orrington Farms Chicken Flavored Broth Base & Seasoning, Low Sodium labels were placed on jars of Orrington Farms Beef Flavored Broth Base & Seasoning, Low Sodium.

LEEP Radius Loop Electrode (CooperSurgical) – Mislabeling (2014)

Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

Turbo Troponin I (Siemens) – Performance Issue (2014)