Reprocessed Xcel Bladeless Trocar (H12LP)
Medical device recall Z-0498-2019. Published in FDA’s Enforcement Report on Dec 5, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 5, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 4848 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4848, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number 3727435 3732833 3732851 3752003 3762495 3762972 3765649 3783776 3775681 3779516 3782202 3784430 3786146 3794419 3803918 3810037 3811778 3809891 3821740 3829338 3833206 3834196 3853141 3854774 3861804 3863303 3870240 3873578…
Every code shown here, 1,082 characters
Lot Number 3727435 3732833 3732851 3752003 3762495 3762972 3765649 3783776 3775681 3779516 3782202 3784430 3786146 3794419 3803918 3810037 3811778 3809891 3821740 3829338 3833206 3834196 3853141 3854774 3861804 3863303 3870240 3873578 3881364 3886277 3866398 3890070 3890089 3880942 3894678 3896022 4113667 4118604 4133825 3849330 4138769 4147801 4154685 4158429 4170275 4173170 4187693 4198853 4202332 4235633 4245630 4274018 4282444 4386368 4515596 4459232 4458288 4466644 4467337 4466103 4473956 4474932 4476349 4477829 4479578 4512285 4513266 4530457 4533116 4548738 4551779 4557026 4566912 4572487 4571871 4574911 4576443 4576086 4577407 4581177 4580431 4583936 4589373 4593587 4603588 4597997 4602957 4598476 4607573 4608496 4608514 4615536 4609747 4610175 4610894 4611167 4611179 4612670 4613359 4614603 4618135 4615246 4616746 4659568 4659478 4660191 4671055 4662392 4663276 4664364 4668273 4669208 4672293 4670712 4667846 4668260 4668287 4670139 4674512 4674857 4074165 4672065 4680853 4681245 4683268 4686942 4688031 4688326 4688887 4688894 4690786 4695707 4704437 4698746
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None.
The states and territories these words name
13 states and territories.
Every one of them
- California
- Colorado
- Georgia
- Iowa
- Illinois
- Louisiana
- Maryland
- New Jersey
- Oklahoma
- Pennsylvania
- Texas
- Virginia
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 19, 2018.
- FDA classified it on Nov 27, 2018.
- FDA’s Enforcement Report published it on Dec 5, 2018.
- FDA terminated it on Nov 15, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.