Recall archive / FDA device enforcement

Various convenience packs — FDA record Z-1699-2022

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 convenience packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Classification: Class II
Recalling firm: American Contract Systems, Inc.
Quantity: 118 units
Agency-reported status: Ongoing
Source record identifier: Z-1699-2022

Open the official record

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) LSRHUMTOTPKC, 2104192, 894211, 14881385 2) LSRLMHANDA, 2104221, 901211, 64119577 3) LSRHUMTOTPKC, 2104192, 894211, 14881385 4) LSRTOTJOINTM, 2104301, 888211, 63993926 5) LSRTOTJOINTM, 2104301, 888211, 63993926 6) LSRLMHANDA, 2105101, 883211, 63991195 7) LSRORTHOMINH, 2107221, 818211, 64119458 8) LSRTOTJOINTM, 2107171, 809211, 64116601 9) LSRTOTJOINTM, 2107171, 809211, 64116600 10) LSRSMANTHF, 2107171, 810211, 64116603 11) LSRARTHROSE, 2108251, 785211, 44139253 12) LSRORTHOMINH, 2108251, 778211, 64119583 13) LSRORTHOMINH, 2108251, 778211, 64119582 14) LSRORTHOMINH, 2109162, 754211, 64318299 15) LSRORTHOMINH, 2109162, 754211, 64318298 16) LSRORTHOMINH, 2109162, 754211, 64318717 17) LSRTOTJOINTM, 2109231, 747211, 64319310 18) LSRORTHOMINH, 2110011, 735211, 64318801 19) MKMA57I, 2104061, 909211, 64024798 20) UICA66AG, 2104122, 902211, 64034679 21) FDPD04AB, 2104143, 901211, 64034128 22) UIEB90G, 2104162, 895211, 14779410 23) UIOS80W, 2106291, 825211, 64170682 24) PCTS17E, 2107192, 803211, 64164240 25) AMTK03AF, 2108162, 776211, 64231145 26) UIKN28AN, 2108202, 771211, 64230570 27) UIHN18AP, 2108193, 771211, 64231011 28) UIHN18AP, 2108193, 771211, 64230951 29) TNTK20U, 2108262, 763211, 64237810 30) LMHN50S, 2109023, 758211, 64234603 31) SCAR03U, 2104151, 895211, 44124761-005 32) BHTK51, 2104191, 891211, 63978560-006 33) SETK12E, 2104261, 887211, 63985987-006 34) SETK12E, 2104261, 887211, 63985736-006 35) FHOM26X, 2104301, 882211, 44123694-005 36) UIOS80V, 2105051, 880211, 63984525-006 37) LOAP10B, 2105102, 870211, 63958629-006 38) SLTH18F, 2105102, 870211, 63958630-006 39) FTHD18I, 2105192, 866211, 63956743-006 40) FAUE10AC, 2105241, 858211, 44133505-005 41) SSTK16F, 2105262, 854211, 63955145-006 42) SHKN28C, 2105271, 854211, 64074676-006 43) FLOR01I, 2106072, 842211, 64074728-006 44) CXOS01T, 2106101, 841211, 44128814-005 45) FHSH28AC, 2107022, 818211, 64112048-006 46) SFAR59E, 2107093, 810211, 44244601-005 47) SLUE07D, 2107101, 809211, 64099712-006 48) AHEX25K, 2107162, 803211, 44244629-005 49) AHEX25K, 2107162, 803211, 44244631-005 50) AHEX25K, 2107162, 803211, 44244630-005 51) AHEX25K, 2107162, 803211, 44244628-005 52) FTHD18I, 2107191, 800211, 64098800-006 53) FTHD18I, 2107191, 800211, 64098798-006 54) FTHD18I, 2107191, 800211, 64098797-006 55) FTHD18I, 2107191, 800211, 64098799-006 56) FHTK32AD, 2107241, 795211, 64097109-006 57) SAOR89Z, 2107292, 791211, 64109976-006 58) FHHP63S, 2108022, 789211, 15007401-004 59) SETK12E, 2108052, 785211, 64107496-006 60) CXHA75H, 2108062, 782211, 15003851-005 61) FAUE10AC, 2108141, 775211, 44239520-005 62) SFAR59E, 2108172, 771211, 44239251-005 63) COPO63, 2108201, 769211, 44316565-005 64) BHLE58G, 2108252, 763211, 44315273-005 65) SFTK53H, 2108313, 757211, 64204506-006 66) CBTJ34H, 2109101, 747211, 64209800-006 67) PREX34U, 2109142, 749211, 64208358-006 68) SAAR74T, 2109162, 741211, 44318763-005 69) MESA11O, 2109211, 741211, 64220362-006 70) FHOM26X, 2109222, 737211, 44316980-005 71) ATTO11J, 2109232, 735211, 64220363-006 72) BHEX32D, 2104291, 894211, 64068954-006 73) BHEX32D, 2104291, 894211, 64068953-006 74) DSEX64D, 2105052, 880211, 14954450-004 75) BHHS55C, 2105191, 883211, 64063386-006 76) BHHD71E, 2105212, 863211, 14974551-004 77) BHAR12C, 2105252, 859211, 64063803-006 78) BHAR12C, 2105252, 859211, 64063802-006 79) BHEX32D, 2106091, 847211, 64045606-006 80) BHEX32D, 2106081, 847211, 64046915-006 81) BHHS55C, 2106082, 848211, 64045553-006 82) UMOR21B, 2106162, 838211, 44210738-005 83) NCTH24J, 2106303, 821211, 64090017-006 84) BHAR12C, 2107091, 820211, 64089228-006 85) BHHS55C, 2107091, 826211, 64088772-006 86) BHHS55C, 2107091, 826211, 64088773-006 87) BHHD26F, 2107221, 803211, 44227720-005 88) BHHD26F, 2107221, 803211, 44227722-005 89) BHHD26F, 2107221, 803211, 44227721-005 90) BHHS55C, 2107271, 798211, 64096266-006 91) BHEX32D, 2108092, 784211, 64094371-006 92) BHEX32D, 2108092, 784211, 64094370-006 93) BHEX32D, 2108092, 784211, 64094201-006 94) BHEX32D, 2108092, 784211, 64094200-006 95) BHEX32D, 2108092, 784211, 64094199-006 96) BHEX32D, 2108092, 784211, 64093655-006 97) BHAR12C, 2108112, 779211, 64093730-006 98) BHAR12C, 2108112, 779211, 64093746-006 99) BHAR12C, 2108112, 779211, 64093745-006 100) BHHS55C, 2108131, 777211, 64093727-006 101) NCTK31J, 2109083, 756211, 63998080-006 102) BHEX32D, 2109141, 748211, 64310593-006 103) BHEX32D, 2109141, 748211, 64310594-006 104) BHEX32D, 2109141, 748211, 64310759-006 105) BHEX32D, 2109141, 748211, 64310592-006 106) BHHS55C, 2109212, 747211, 64310388-006 107) DRSP17A, 2104141, 903211, 63861576-006 108) DRSP17A, 2104141, 903211, 63861575-006 109) SATO27E, 2104091, 904211, 64009103-006 110) WHTK06B, 2106301, 826211, 64130783-006 111) MPKK10B, 2107061, 818211, 64128810-006 112) UTSA18P, 2104271, 888211, 44175244-005 113) UTSA18P, 2104271, 888211, 44175243-005 114) UTSA18P, 2104271, 888211, 44175238-005 115) UTSA18P, 2104271, 888211, 44175235-005 116) GREX13I, 2105041, 877211, 14912665-004 117) AHSC20B, 2107061, 821211, 44167441-005 118) AHKA41C, 2109221, 740211, 64285900-006

Label field

Details supplied by the agency

Lot, code or applicability

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHUMTOTPKC, 2104192, 894211, 14881385 2) LSRLMHANDA, 2104221, 901211, 64119577 3) LSRHUMTOTPKC, 2104192, 894211, 14881385 4) LSRTOTJOINTM, 2104301, 888211, 63993926 5) LSRTOTJOINTM, 2104301, 888211, 63993926 6) LSRLMHANDA, 2105101, 883211, 63991195 7) LSRORTHOMINH, 2107221, 818211, 64119458 8) LSRTOTJOINTM, 2107171, 809211, 64116601 9) LSRTOTJOINTM, 2107171, 809211, 64116600 10) LSRSMANTHF, 2107171, 810211, 64116603 11) LSRARTHROSE, 2108251, 785211, 44139253 12) LSRORTHOMINH, 2108251, 778211, 64119583 13) LSRORTHOMINH, 2108251, 778211, 64119582 14) LSRORTHOMINH, 2109162, 754211, 64318299 15) LSRORTHOMINH, 2109162, 754211, 64318298 16) LSRORTHOMINH, 2109162, 754211, 64318717 17) LSRTOTJOINTM, 2109231, 747211, 64319310 18) LSRORTHOMINH, 2110011, 735211, 64318801 19) MKMA57I, 2104061, 909211, 64024798 20) UICA66AG, 2104122, 902211, 64034679 21) FDPD04AB, 2104143, 901211, 64034128 22) UIEB90G, 2104162, 895211, 14779410 23) UIOS80W, 2106291, 825211, 64170682 24) PCTS17E, 2107192, 803211, 64164240 25) AMTK03AF, 2108162, 776211, 64231145 26) UIKN28AN, 2108202, 771211, 64230570 27) UIHN18AP, 2108193, 771211, 64231011 28) UIHN18AP, 2108193, 771211, 64230951 29) TNTK20U, 2108262, 763211, 64237810 30) LMHN50S, 2109023, 758211, 64234603 31) SCAR03U, 2104151, 895211, 44124761-005 32) BHTK51, 2104191, 891211, 63978560-006 33) SETK12E, 2104261, 887211, 63985987-006 34) SETK12E, 2104261, 887211, 63985736-006 35) FHOM26X, 2104301, 882211, 44123694-005 36) UIOS80V, 2105051, 880211, 63984525-006 37) LOAP10B, 2105102, 870211, 63958629-006 38) SLTH18F, 2105102, 870211, 63958630-006 39) FTHD18I, 2105192, 866211, 63956743-006 40) FAUE10AC, 2105241, 858211, 44133505-005 41) SSTK16F, 2105262, 854211, 63955145-006 42) SHKN28C, 2105271, 854211, 64074676-006 43) FLOR01I, 2106072, 842211, 64074728-006 44) CXOS01T, 2106101, 841211, 44128814-005 45) FHSH28AC, 2107022, 818211, 64112048-006 46) SFAR59E, 2107093, 810211, 44244601-005 47) SLUE07D, 2107101, 809211, 64099712-006 48) AHEX25K, 2107162, 803211, 44244629-005 49) AHEX25K, 2107162, 803211, 44244631-005 50) AHEX25K, 2107162, 803211, 44244630-005 51) AHEX25K, 2107162, 803211, 44244628-005 52) FTHD18I, 2107191, 800211, 64098800-006 53) FTHD18I, 2107191, 800211, 64098798-006 54) FTHD18I, 2107191, 800211, 64098797-006 55) FTHD18I, 2107191, 800211, 64098799-006 56) FHTK32AD, 2107241, 795211, 64097109-006 57) SAOR89Z, 2107292, 791211, 64109976-006 58) FHHP63S, 2108022, 789211, 15007401-004 59) SETK12E, 2108052, 785211, 64107496-006 60) CXHA75H, 2108062, 782211, 15003851-005 61) FAUE10AC, 2108141, 775211, 44239520-005 62) SFAR59E, 2108172, 771211, 44239251-005 63) COPO63, 2108201, 769211, 44316565-005 64) BHLE58G, 2108252, 763211, 44315273-005 65) SFTK53H, 2108313, 757211, 64204506-006 66) CBTJ34H, 2109101, 747211, 64209800-006 67) PREX34U, 2109142, 749211, 64208358-006 68) SAAR74T, 2109162, 741211, 44318763-005 69) MESA11O, 2109211, 741211, 64220362-006 70) FHOM26X, 2109222, 737211, 44316980-005 71) ATTO11J, 2109232, 735211, 64220363-006 72) BHEX32D, 2104291, 894211, 64068954-006 73) BHEX32D, 2104291, 894211, 64068953-006 74) DSEX64D, 2105052, 880211, 14954450-004 75) BHHS55C, 2105191, 883211, 64063386-006 76) BHHD71E, 2105212, 863211, 14974551-004 77) BHAR12C, 2105252, 859211, 64063803-006 78) BHAR12C, 2105252, 859211, 64063802-006 79) BHEX32D, 2106091, 847211, 64045606-006 80) BHEX32D, 2106081, 847211, 64046915-006 81) BHHS55C, 2106082, 848211, 64045553-006 82) UMOR21B, 2106162, 838211, 44210738-005 83) NCTH24J, 2106303, 821211, 64090017-006 84) BHAR12C, 2107091, 820211, 64089228-006 85) BHHS55C, 2107091, 826211, 64088772-006 86) BHHS55C, 2107091, 826211, 64088773-006 87) BHHD26F, 2107221, 803211, 44227720-005 88) BHHD26F, 2107221, 803211, 44227722-005 89) BHHD26F, 2107221, 803211, 44227721-005 90) BHHS55C, 2107271, 798211, 64096266-006 91) BHEX32D, 2108092, 784211, 64094371-006 92) BHEX32D, 2108092, 784211, 64094370-006 93) BHEX32D, 2108092, 784211, 64094201-006 94) BHEX32D, 2108092, 784211, 64094200-006 95) BHEX32D, 2108092, 784211, 64094199-006 96) BHEX32D, 2108092, 784211, 64093655-006 97) BHAR12C, 2108112, 779211, 64093730-006 98) BHAR12C, 2108112, 779211, 64093746-006 99) BHAR12C, 2108112, 779211, 64093745-006 100) BHHS55C, 2108131, 777211, 64093727-006 101) NCTK31J, 2109083, 756211, 63998080-006 102) BHEX32D, 2109141, 748211, 64310593-006 103) BHEX32D, 2109141, 748211, 64310594-006 104) BHEX32D, 2109141, 748211, 64310759-006 105) BHEX32D, 2109141, 748211, 64310592-006 106) BHHS55C, 2109212, 747211, 64310388-006 107) DRSP17A, 2104141, 903211, 63861576-006 108) DRSP17A, 2104141, 903211, 63861575-006 109) SATO27E, 2104091, 904211, 64009103-006 110) WHTK06B, 2106301, 826211, 64130783-006 111) MPKK10B, 2107061, 818211, 64128810-006 112) UTSA18P, 2104271, 888211, 44175244-005 113) UTSA18P, 2104271, 888211, 44175243-005 114) UTSA18P, 2104271, 888211, 44175238-005 115) UTSA18P, 2104271, 888211, 44175235-005 116) GREX13I, 2105041, 877211, 14912665-004 117) AHSC20B, 2107061, 821211, 44167441-005 118) AHKA41C, 2109221, 740211, 64285900-006

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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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