Fresh Recalls

Brand Name: recall status

Notice names this product. Clinical Innovations’s Brand Name is named in FDA Class II recall Z-1945-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to complaints of device breakage at the traction force gauge to handle joint. Identifying details: Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681. Units affected: 49,175 devices. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Brand Name
Company / brand
Clinical Innovations
Lot / serial / date codes
Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MI, MN, MS, NC, NE, NH, NV, NY, OH, PR, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.
Agency product description and boundaries

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Clinical Innovations

Recalls naming this model

FDA Class II · Medical device · May 6, 2026

Brand Name recall — Clinical Innovations, LLC

Due to complaints of device breakage at the traction force gauge to handle joint.

Company / brand: Clinical Innovations recalls

Affected product: Brand Name recall status

Official ID Z-1945-2026 · Official record ↗

See all Clinical Innovations recalls →

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.