Recall Register

Food, drugs, devices › Firms

ETHICON, LLC

FDA recalling firm · 3 enforcement events · 6 product records · 2023–2025 · PR

ETHICON, LLC has 3 FDA enforcement events on this register (6 product records) between 2023 and 2025: 3 device; the busiest year was 2023 with 1.

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

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

InitiatedProduct (first record)TypeClassRecordsStatus
15 Aug 2025STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.DeviceClass II1Ongoing
20 Dec 2024PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.DeviceClass II3Ongoing
10 Aug 2023PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40,…DeviceClass II2Ongoing

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

23
24
25
26
Enforcement events for ETHICON, LLC by year initiated.

Questions and answers

How many FDA recalls has ETHICON, LLC had?

3 enforcement events (6 product records) on this register, 2023–2025: 3 device.

Are any ETHICON, LLC recalls ongoing?

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

What class are ETHICON, 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.