Z-Medica, LLC

FDA recalling firm · 3 enforcement events · 3 product records · 2017–2021 · CT

Z-Medica, LLC has 3 FDA enforcement events on this register (3 product records) between 2017 and 2021: 3 device; the busiest year was 2017 with 2.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in CT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
22 Sep 2021	QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200	Device	Class II	1	Terminated
17 Nov 2017	QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries	Device	Class II	1	Terminated
17 May 2017	QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for…	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Z-Medica, LLC by year initiated.

Questions and answers

How many FDA recalls has Z-Medica, LLC had?

3 enforcement events (3 product records) on this register, 2017–2021: 3 device.

Are any Z-Medica, LLC recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Z-Medica, LLC recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.