Aspen Surgical Products, Inc. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400Class IIJul 23, 2021Affected products were manufactured with materials found to	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at whic	Class IIDevices	Jul 23, 2021
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300Class IIJul 23, 2021Affected products were manufactured with materials found to	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at whic	Class IIDevices	Jul 23, 2021
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100Class IIJul 23, 2021Affected products were manufactured with materials found to	Affected products were manufactured with materials found to have a bioburden level exceeding the limit at whic	Class IIDevices	Jul 23, 2021