LapSac Surgical Tissue Pouch
Medical device recall Z-1830-2015. Published in FDA’s Enforcement Report on Jul 1, 2015.
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 Jul 1, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 123,184 devices were distributed in commerce 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?
Includes Information not stated in the intended use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
123,184 devices were distributed in commerce, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
RPN: C-LSP-10-8; LapSac Surgical Tissue Pouch, Lot Numbers: 5723441 5623670 5551679 5385865 5101403 4499389 5150312 4872587 4701001 4573324 4475653 4475656 5083283 4994401 4475654 4349570 5647029 5189488 4592116 5222585 5466530 4678791…
Every code shown here, 1,999 characters
RPN: C-LSP-10-8; LapSac Surgical Tissue Pouch, Lot Numbers: 5723441 5623670 5551679 5385865 5101403 4499389 5150312 4872587 4701001 4573324 4475653 4475656 5083283 4994401 4475654 4349570 5647029 5189488 4592116 5222585 5466530 4678791 5128670 5647027 4960012 5239097 4976472 4898631 4763679 5371589 5578854 5184529 4696047 5443887 5512804 5578850 5138475 5495760 5316304 4351774 4310027 5202853 4617104 4892305 5754071 4956583 4803582 5689985 4757759 4736751 5739139 4861864 4861859 4828636 4522443 5047841 5010495 4536914 4717500 4408864 5252563 5065112 4939988 4678785 5301513 4706480 4939982 4872587X 4806612 5010492 4599491 4939983 4960014 4884781 5128670X 5101403X 4701001X 5047841X RPN: C-LSP-5-2; LapSac Surgical Tissue Pouch, Lot Numbers: F4621972 NS5273151 NS5138472 NS5047844 F4706481 NS5614093 F4803584 NS5614097 NS5189486 NS5473679 NS5451672 NS5076019 NS4983975 F4806611 F4717499 F4678774 F4544216 F4530236 F4399198 NS5647028 NS5316295 NS5202849 F4787623 F4653284 F4592117 NS5739140 F4653283 NS5032341 NS5754072 NS5578855 NS5512803 NS5443889 NS5316303 NS5164953 NS5150316 NS5057498 NS4983976 F4868019 NS5032337 F4562966 NS5032338 NS4976473 NS5239098 NS5647030 NS5578857 NS5443890 NS5189485 NS5614096 NS5301514 NS5047843 NS5670442 NS5456926 F4822785 F4612006 NS5409553 NS5409552 F4475655 NS5456925 F4884782 NS5647024 NS5385861 F4678778 NS4939987 NS5334276 NS5273150 F4811161 F4803587 NS5481611 NS5334277 F4408861 NS5614094 NS5047845 F4774686 F4373157 NS4939986 NS5551680 NS5512806 NS5495762 NS5473682 NS5443888 NS5371590 F4822786 F4604065 F4568338 NS5578856 NS5551682 NS5523837 NS5647025 NS5035754 NS5032339 NS5010496 NS5618271 NS5512805 NS5495763 RPN: C-LSP-6-4; LapSac Surgical Tissue Pouch, Lot Numbers: 4382550 5523836 4617105 4499391 4706482 4696048 5451671 5092465 5169730 5150315 5296792 5114844 5631020 5353350 5495764 5584262 4828635 4349571 4678790 4787624 4803579 4803585 4745252 5076017 4604063 4833964 4822789 4544215 4373154 4868018 4878865 5189487 4280701 4592114 4653279…
FDA’s list runs to 24,326 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide Distribution - US (nationwide) including PR and to the states of: AZ, AK, AL, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, ME, MT, NC, ND, NE, NH, NJ, NY, NM, OH,OK,OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and to the countries of : China, Korea, Denmark, Mexico, New Zealand, India and Colombia.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 May 14, 2015.
- FDA classified it on Jun 24, 2015.
- FDA’s Enforcement Report published it on Jul 1, 2015.
- FDA terminated it on Sep 12, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Inc., of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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.”
- FDA’s list of codes runs to 24,326 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.