Stryker Corporation: Medical Device Recall in 2018 - (Recall #: Z-0836-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

Product Classification:

Class II

Date Initiated: November 17, 2017

Date Posted: March 14, 2018

Recall Number: Z-0836-2018

Event ID: 78668

Reason for Recall:

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Status: Terminated

Product Quantity: 60,753 units total

Code Information:

a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

Distribution Pattern:

Distributed domestically to . Distributed internationally to Australia and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated