FDA Device recall Z-1830-2015

LapSac Surgical Tissue Pouch

FDA Device
Class II
terminated
Published 2015-07-01

On 2015-07-01 the FDA classified a Class II recall of LapSac Surgical Tissue Pouch by Cook, citing includes Information not stated in the intended use.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1830-2015
Classification	Class II
Status	terminated
Initiated	2015-05-14
Published	2015-07-01
Last updated	2026-09-13 11:53 UTC
Company	Cook
Distribution	US

Product

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.

Reason

Includes Information not stated in the intended use.

Identifiers

code_info	RPN: C-LSP-10-8; LapSac Surgical Tissue Pouch, Lot Numbers: 5723441 5623670 5551679 5385865 5101403 4499389 5… 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 F

code_info

RPN: C-LSP-10-8; LapSac Surgical Tissue Pouch, Lot Numbers: 5723441 5623670 5551679 5385865 5101403 4499389 5…

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 F

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1830-2015%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.