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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88476

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 23, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aspen Surgical Products, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300

Z-2388-2021
Recall number
Z-2388-2021
Initiated
July 23, 2021
Classification
Class II
Status
Terminated
Quantity
1429

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
found to have a bioburden

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

Code information

All lots manufactured between July 9, 2019 to July 9, 2021

Distribution pattern

US nationwide distribution. No foreign distribution.

device · product 2 of 3

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

Z-2389-2021
Recall number
Z-2389-2021
Initiated
July 23, 2021
Classification
Class II
Status
Terminated
Quantity
4270

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
found to have a bioburden

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

Code information

All lots manufactured between July 9, 2019 to July 9, 2021

Distribution pattern

US nationwide distribution. No foreign distribution.

device · product 3 of 3

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Z-2390-2021
Recall number
Z-2390-2021
Initiated
July 23, 2021
Classification
Class II
Status
Terminated
Quantity
124

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
found to have a bioburden

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

Code information

All lots manufactured between July 9, 2019 to July 9, 2021

Distribution pattern

US nationwide distribution. No foreign distribution.