Medical device recalls

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).

Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

Two specific lots was incorrectly manufactured containing a UK power adapter.

The video cytoscopes lack 510(k) premarket notification clearance.

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

Cut resistant surgical glove liners lack sterility assurance.

Abutments are unable to accept the final abutment screw

Contamination with Methylbacterium thiocyanatum

The firm information that the product was reporting false positive results

Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.

The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

Vix Bit may fracture during use.

Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.