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Syntervention

ZIEN MEDICAL TECHNOLOGIES, INC. · Model 4008-309 · UDI-DI 00850049994965

GDY Prescription

510(k) clearances

2,553

Adverse events (3 deaths)

Recalls

207

Facilities

Description

SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent sponge intended for use in a variety of surgical or medical procedures. SWICKER can be used in multiple surgical procedures and areas including patient prepping, open surgery, instrument padding, instrument cleaning, and wound care. SWICKER Radiopaque Sponge 2 Pack, 9" x 9" x .25"

Recalls

Date	Firm	Reason
2026-06-01	Argon Medical Devices, Inc	Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
2025-07-01	Carefree Surgical Specialties	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
2025-07-01	Carefree Surgical Specialties	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
2025-07-01	Carefree Surgical Specialties	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
2025-07-01	Carefree Surgical Specialties	Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
2024-02-21	Covidien	Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't
2022-01-24	Argon Medical Devices, Inc	Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor bl
2021-08-11	Cypress Medical Products LLC	Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators di
2020-04-08	Argon Medical Devices, Inc	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may
2020-04-08	Argon Medical Devices, Inc	Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.