ModerateClass IITerminated

FDA Devices recall · Reported July 1, 2015

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1830-2015.

Q: Where was the recalled product distributed?

Distribution: 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..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Includes Information not stated in the intended use.

Recall #: Z-1830-2015
Affected scope: 123,184 devices were distributed in commerce
Initiated: May 14, 2015

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Cook Inc. recalled LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue… - a moderate-severity action.

LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue… was recalled by Cook Inc. in July 1, 2015. Reason: Includes Information not stated in the intended use.. Check the official notice for the remedy. Verify recall #Z-1830-2015 with the FDA Devices before acting.

The recall

Cook Inc. issued this moderate-severity FDA Devices recall-Includes Information not stated in the intended use..

Moderate
severity level: 123K units
affected scope: Class II
classification: July 1, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1830-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 for recall

Includes Information not stated in the intended use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1830-2015
Date reported	July 1, 2015
Date initiated	May 14, 2015
Recalling firm	Cook Inc.
Firm location	Bloomington, IN
Affected scope	123,184 devices were distributed in commerce
Distribution	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, …

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

123,184 devices were distributed in commerce units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1830-2015) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Includes Information not stated in the intended use.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1830-2015.

Where was the recalled product distributed? ▼

Distribution: 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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Otteroo Recalls Baby Floats Due to Drowni… 2015-07-01 ACURA 2014-2015: EQUIPMENT:APPLIANCE:AIR … 2015-07-01 Jivara Lactee Milk Chocolate Valrhona; 40… 2015-07-01 Eating Right Black Bean Soup; 1.3 oz pape… 2015-07-01

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Lifesaver Single Patient Use Manual Resus… 2015-07-01 ORTHOFIX Centurion POCT System Drill Guid… 2015-07-01 Sure T, contact, contact detach, neria, n… 2015-07-01 ULTRA-FAST FIX Knot Pusher Suture Cutters… 2015-07-01

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported July 1, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026