FDA recall Z-3146-2026

Product

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);

Reason for recall

The packaging may not consistently maintain sterile barrier integrity.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;

Key facts

Status

Ongoing

Initiation date

2026-07-31

Report date

2026-09-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rastatt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3146-2026