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UnnaCare 4x4

SUN SCIENTIFIC, INC. · Model ZO1050-00 · UDI-DI 00856525007891

FQM Prescription

510(k) clearances

299

Adverse events

Recalls

698

Facilities

Description

A 4" x4"sterile or non sterile strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return).it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Recalls

Date	Firm	Reason
2026-02-27	Medline Industries, LP	Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2024-04-02	Andover Healthcare Inc.	A packaging seal gap could impact the sterility of the product.
2022-06-22	ASO LLC	The product falls apart during handling after removal from its primary packaging.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-02-01	BSN Medical Inc	The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
2020-08-21	North American Rescue LLC.	Lack of sterility assurance of the 30-0171
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product
2019-06-19	Andover Healthcare Inc.	Incomplete packaging seal of sterile product

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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.