Medical device recalls

FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

A potential commingle that could result in the product in the package not matching the product on the outer label.

A potential commingle that could result in the product in the package not matching the product on the outer label.

There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.

There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.

Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.

There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

The secondary packaging is labeled with an incorrect expiration date.

There is a potential for the connection screw of the stem extractor to break.

There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.

Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Separation of material layers may occur, causing a potential risk of exposure to contaminants.

Separation of material layers may occur, causing a potential risk of exposure to contaminants.