FDA Device recall Z-2533-2018
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120394…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120394… by Ethicon, citing products do not meet a tensile strength specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2533-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon |
| Distribution | n/a |
Product
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
Reason
Products do not meet a tensile strength specification
Identifiers
| code_info | Lot Number:MCZ162 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Ethicon
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FDA Device · Class II · 2026-10-21 · Ethicon - STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod…
FDA Device · Class II · 2025-10-01 · Ethicon - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.