Arkansas recalls

A potential issue with the seal integrity of header bag packaging.

A potential issue with the seal integrity of header bag packaging.

A potential issue with the seal integrity of header bag packaging.

It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Shrimp may be contaminated with Cesium-137 (Cs-137).

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

The recalled bed rails violate the mandatory standard for children's portable bed rails because, when installed adjacent to the bed, the child can become entrapped in the enclosed openings, the openings on the side of the mattress, and the openings on top of the mattress, posing a risk of serious injury or death due to entrapment.

The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire.

The pump's canister can forcefully eject from the base when pressurized, posing a risk of serious injury from impact to the user or bystander.

The recalled bed rails violate the mandatory standard for adult portable bed rails, posing a serious entrapment hazard and risk of death by asphyxiation. When the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. In addition, the bed rails do not have the required warning labels.

The recalled toys are intended for children under three years of age and the eyes can detach, which violates the small parts ban, posing a choking hazard to children.