RecallRadar

FDA Device recall Z-1336-2020

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

On 2020-02-26 the FDA classified a Class II recall of 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 by Ethicon, citing the product do not meet certain internal testing specifications.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1336-2020
ClassificationClass II
Statusterminated
Initiated2019-08-28
Published2020-02-26
Last updated2026-09-13 11:55 UTC
CompanyEthicon
Distributionn/a

Product

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

Reason

The product do not meet certain internal testing specifications.

Identifiers

code_infoGTIN: 10705031235816 Lot Number: PAH166 Expiration Date: 12/31/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2020%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.