Recall archive / FDA device enforcement
Various Laparoscopy Packs — FDA record Z-1694-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Various Laparoscopy Packs
- Reason
- Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- Classification
- Class II
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 39 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1694-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRENDOSCOPH, 2104281, 890211, 14887854 2) LSRENDOSCOPH, 2108251, 784211, 44375070 3) LSRENDOSCOPH, 2110011, 740211, 15140201 4) PLLA88I, 2104162, 895211, 14779054 5) AMGL09X, 2104281, 887211, 64029666 6) IHGB89AB, 2107293, 791211, 64104353 7) UIUA68AG, 2108202, 771211, 64233083 8) FRLC65S, 2104301, 882211, 44123696-005 9) MHLC19AH, 2105181, 863211, 63956744-006 10) CXRO12W, 2107082, 811211, 64110751-006 11) SLLP38F, 2107132, 807211, 64100877-006 12) SLLP38F, 2107132, 807211, 64100879-006 13) SLLP38F, 2107132, 807211, 64100878-006 14) CXLP87AJ, 2107162, 803211, 15011547-004 15) BHLC43J, 2108042, 784211, 44294507-005 16) BHLC43J, 2108042, 784211, 44234508-005 17) MERS50Q, 2108193, 769211, 64206337-006 18) BHRP78C, 2104131, 903211, 64073208-006 19) BHRP78C, 2104131, 903211, 64073209-006 20) BHRP78C, 2106221, 831211, 64091105-006 21) BHRP78C, 2106221, 831211, 64091104-006 22) BHRP78C, 2106233, 831211, 64090598-006 23) BHLP21C, 2107261, 800211, 44226340-005 24) BHLP21C, 2107261, 800211, 44226339-005 25) BHLP21C, 2107261, 800211, 44226341-005 26) BHLP21C, 2107261, 800211, 44226338-005 27) BHLP62E, 2107292, 799211, 44219340-005 28) BHLP62E, 2107292, 799211, 44219343-005 29) BHLP62E, 2107292, 799211, 44219342-005 30) BHLP62E, 2107292, 799211, 44219341-005 31) BHRP78C, 2108041, 789211, 64093909-006 32) BHRP78C, 2108041, 789211, 64092459-006 33) BHRP78C, 2108041, 789211, 64092460-006 34) BHLP62E, 2108242, 771211, 44336911-005 35) SARB30J, 2104291, 884211, 64040187-006 36) MCLC14F, 2106011, 853211, 44153023-005 37) MPRO72D, 2107131, 811211, 64129494-006 38) MCLC14F, 2109031, 760211, 44261569-005 39) AGLC19L, 2108191, 775211, 64186775-006 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Jun 16, 2022
- Center classification date
- Sep 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.