Reported Sep 14, 2022 · Ongoing

Various Laparoscopy Packs

American Contract Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Contract Systems, Inc. · 2610 Ne Industrial Dr Ste 220 · Kansas City, MO · 64117-2648

Is this the product you have?

  • Various Laparoscopy Packs
Lot codes and dates

39 of 39 products

Products covered by this recall
#Product as published
1LSRENDOSCOPH, 2104281, 890211, 14887854
2LSRENDOSCOPH, 2108251, 784211, 44375070
3LSRENDOSCOPH, 2110011, 740211, 15140201
4PLLA88I, 2104162, 895211, 14779054
5AMGL09X, 2104281, 887211, 64029666
6IHGB89AB, 2107293, 791211, 64104353
7UIUA68AG, 2108202, 771211, 64233083
8FRLC65S, 2104301, 882211, 44123696-005
9MHLC19AH, 2105181, 863211, 63956744-006
10CXRO12W, 2107082, 811211, 64110751-006
11SLLP38F, 2107132, 807211, 64100877-006
12SLLP38F, 2107132, 807211, 64100879-006
13SLLP38F, 2107132, 807211, 64100878-006
14CXLP87AJ, 2107162, 803211, 15011547-004
15BHLC43J, 2108042, 784211, 44294507-005
16BHLC43J, 2108042, 784211, 44234508-005
17MERS50Q, 2108193, 769211, 64206337-006
18BHRP78C, 2104131, 903211, 64073208-006
19BHRP78C, 2104131, 903211, 64073209-006
20BHRP78C, 2106221, 831211, 64091105-006
Amount recalled
39 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

Why it was recalled

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.