Medical Devices Recalls

The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.

Small sized specula were incorrectly packaged in printed bags for the medium sized speculum

Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.

Use of the recalled product may result in false positive reports.

Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

The intake port may be blocked which can cause the bag to fail to fill.

The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.

Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.

There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.

Use of the recalled product may result in false positive reports.

Potential component failure resulting in inoperability

During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture

Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes

There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.