Reprocessed Xcel Bladeless Trocar — Class II medical device recall Z-0498-2019
Terminated recall by Stryker Sustainability Solutions, reported 2018-12-05, distributed nationwide. Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distribut
| Recall number | Z-0498-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2018-06-19 |
| Classified | 2018-11-27 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2024-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 4,848 |
| Lot numbers | 3727435, 3732833, 3732851, 3752003, 3762495, 3762972, 3765649, 3775681, 3779516, 3782202, 3783776, 3784430, 3786146, 3794419, 3803918, 3809891, 3810037, 3811778, 3821740, 3829338, 3833206, 3834196, 3849330, 3853141, 3854774, 3861804, 3863303, 3866398, 3870240, 3873578, 3880942, 3881364, 3886277, 3890070, 3890089, 3894678, 3896022, 4074165, 4113667, 4118604 and 94 more |
| Model numbers | H12LP |
Product
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Reason for recall
Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0498-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.