Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87542

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 05, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien

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

1 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 1

Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

Z-1411-2021
Recall number
Z-1411-2021
Initiated
March 05, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Covidien
Quantity
59,828 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

Code information

UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914

Distribution pattern

Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.