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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90574

17 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 16, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
American Contract Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

17 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 17

Various Angiography packs/trays

Z-1689-2022
Recall number
Z-1689-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRANGIRM21G,2105111, 874211, 63991913 3) LSRCFHANGD,2106031, 854211, 14887381 4) LSRARTDATANGA,2107102, 821211, 44256256 5) LSRARTDATANGA,2107102, 821211, 44256255 6) LSRARTDATANGA,2110011, 742211, 44373255 7) LSRARTDATANGA,2110011, 742211, 44373260 8) LMAN19U,2106292, 824211, 64169682 9) IHAN02S,2108111, 782211, 64190032 10) ANCA80AG,2109161, 743211, 64222813 11) SLPC34,2104022, 908211, 44127417-005 12) MHHY51F,2104151, 895211, 63978560-006 13) CXAN39N,2105072, 873211, 14875221-004 14) FHAG11X,2105072, 873211, 44111418-005 15) MHIR99AF,2105132, 868211, 63958625-006 16) BHAN91L,2105211, 860211, 44107976-005 17) ANCA80AG,2105212, 860211, 63956879-006 18) UDIN23AB,2105253, 855211, 63955146-006 19) SLPC34H,2106011, 853211, 44130251-005 20) SLPC34H,2106232, 827211, 43995487-005 21) SLPC34H,2106232, 827211, 43995488-005 22) FHAG11X,2106252, 825211, 43993760-005 23) FHAG11X,2106252, 825211, 44247863-005 24) SLPC34H,2107082, 817211, 44245946-005 25) CXAN39N,2107261, 793211, 15007653-004 26) CXAN39N,2107261, 793211, 15007652-004 27) UDCO10A,2107292, 790211, 64109977-006 28) BHAN91L,2107302, 789211, 44235082-005 29) FHAG11X,2108102, 778211, 44240799-005 30) FHAG11X,2108102, 778211, 44240798-005 31) BHAN91,2108131, 776211, 44240114-005 32) SLPC34H,2108242, 764211, 44315271-005 33) SLPC34H,2108242, 764211, 44315270-005 34) BHAN91L,2109101, 748211, 44320300-005 35) FHAG11X,2109151, 742211, 44318761-005 36) SLPC34H,2109232, 734211, 44316981-005 37) NCAG62G,2105252, 860211, 64063801-006 38) TMAN84F,2106162, 838211, 64044558-006 39) TMAN84F,2106162, 838211, 64044569-006 40) GSAN26D,2108131, 778211, 44216057-005 41) GSAN26D,2108131, 778211, 44215917-005 42) CGSP34G,2108271, 764211, 44336891-005 43) CGSP34G,2108271, 764211, 44336906-005 44) CGSP34G,2108271, 764211, 44336889-005 45) CGSP34G,2108271, 764211, 44336890-005 46) GSAN26D,2109271, 735211, 44353838-005 47) GSAN26D,2109271, 735211, 44353837-005 48) GSAN26D,2109271, 735211, 44353836-005 49) SJAR31F,2104211, 894211, 14702002-004 50) SJMY36D,2105241, 859211, 14894016-004 51) WHAI40C,2106071, 844211, 64133103-006 52) SSAR20D,2106151, 838211, 14893801-004 53) SJAR31F,2107191, 805211, 15031953-004 54) MPRM25D,2107261, 797211, 15028609-004 55) SJAR31F,2108231, 769211, 15025673-004 56) SJAR31F,2109141, 743211, 15023697-004 57) WHAI40C,2109241, 735211, 64135103-006

Distribution pattern

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

device · product 2 of 17

Various Angiography/Cath Lab packs/trays

Z-1690-2022
Recall number
Z-1690-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCUSTCATHG,2104091, 911211, 44064504 2) LSRCARDCATHG,2105191, 874211, 14884701 3) LSRCARDCATHG,2106031, 861211, 14887382 4) LSRCFHCATHD,2106151, 839211, 14887387 5) LSRCARDCATHG,2106172, 842211, 14882944 6) LSRCARDCATHG,2106172, 842211, 14887386 7) LSRCUSTCATHG,2106181, 840211, 44251069 8) LSRCFHCATHD,2107102, 810211, 15020227 9) LSRCFHCATHD,2107102, 810211, 15020826 10) LSRCFHCATHD,2107262, 807211, 15020266 11) LSRSPECPROCF,2107262, 803211, 64117654 12) LSRCARDCATHG,2108171, 783211, 44139783 13) LSRCFHCATHD,2109071, 765211, 44376128 14) LSRCFHCATHD,2109071, 765211, 44376127 15) LSRCFHCATHD,2109071, 765211, 44376129 16) LSRCFHCATHD,2109071, 765211, 44376130 17) LSRCUSTCATHG,2109201, 754211, 44373704 18) LSRCFHCATHD,2109271, 740211, 15142078 19) MMCC14D,2104143, 898211, 64033893 20) IHCC03R,2107061, 819211, 44183402 21) HGCL69G,2107202, 803211, 15053840 22) UIRD89AE,2107293, 793211, 44181939 23) AMCL05M,2108131, 777211, 64230198 24) HGCL69G,2108313, 761211, 15062583 25) SHCA31I,2105142, 866211, 44111393-005 26) CXDP36N,2105241, 858211, 14854252-004 27) SHCA31I,2105261, 855211, 44131698-005 28) BLCL72K,2106141, 835211, 14994491-004 29) SACL75AK,2106212, 828211, 64071585-006 30) MECL20V,2107292, 805211, 44235192-005 31) SACL75AK,2107302, 789211, 64109974-006 32) SLBT02H,2108051, 784211, 44234510-005 33) AHCC27X,2109092, 748211, 64209383-006 34) BHCA49I,2107161, 817211, 44228705-005 35) BHCA49I,2107161, 817211, 44228708-005 36) SHCC17E,2107292, 793211, 44219151-005 37) SHIR38E,2108192, 721211, 14977781-004 38) BHCA49I,2108241, 768211, 44215236-005 39) BHCA49I,2108241, 768211, 44335430-005 40) BHCA49I,2108241, 768211, 44336206-005 41) TMCC25I,2108312, 764211, 63999207-006 42) TMCC25I,2108312, 764211, 63999208-006 43) TMCC25I,2108312, 764211, 63999206-006 44) TMCC25I,2108312, 764211, 63999205-006 45) TMCC25I,2108312, 764211, 63999204-006 46) SHDW24G,2109071, 754211, 44344585-005 47) SHDW24G,2109071, 754211, 44344586-005 48) SHDW24G,2109071, 754211, 44344587-005 49) SHDW24G,2109071, 754211, 44344588-005 50) SHDW24G,2109071, 754211, 44344589-005 51) MPCA63J,2104141, 917211, 64008477-006 52) SJCH22F,2106141, 840211, 64133201-006 53) MCCP02G,2106151, 838211, 64131832-006 54) WHAC86C,2106161, 835211, 64132953-006 55) MCCP02G,2107231, 798211, 64141288-006 56) SNCP60F,2108041, 788211, 64141247-006 57) MCCP02G,2109131, 753211, 64134924-006 58) MCCP02G,2109131, 753211, 64135604-006 59) FBHC45H,2105131, 870211, 14576957-004 60) AGLH66F,2106241, 834211, 44167857-005 61) AGLH66G,2108251, 765211, 44288730-005

Distribution pattern

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

device · product 3 of 17

Various Pacemaker Packs, Cardio Thoracic Packs

Z-1691-2022
Recall number
Z-1691-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASING, 2107102, 817211, 64116041 3) LSRSMVEINB, 2107221, 810211, 64119459 4) LSRCFHENDAE, 2107171, 807211, 64116602 5) UICT16E, 2108183, 771211, 15066268 6) BHOH94I, 2104141, 897211, 63987116-006 7) BHOH95, 2104301, 902211, 44123693-005 8) ANCV60AI, 2105201, 860211, 63956881-006 9) UDIP97AD, 2105201, 860211, 14858003-004 10) CEFS17I, 2105262, 855211, 44132805-005 11) FHPM10P, 2106092, 840211, 44129541-005 12) SLCV01E, 2107081, 812211, 64110741-006 13) SLEP03F, 2108271, 761211, 44314505-005 14) SLEP03F, 2108271, 761211, 44314504-005 15) CXCV91X, 2108311, 757211, 44315778-005 16) MECV98V, 2108312, 757211, 44313827-005 17) SAPA90X, 2108311, 758211, 64204754-006 18) SLCV01E, 2109161, 742211, 64208360-006 19) MEEP10F, 2109202, 740211, 64220361-006 20) UMOH42C, 2105072, 876211, 64061399-006 21) BHON40H, 2108122, 778211, 64095875-006 22) BHPM60F, 2108122, 779211, 44216056-005 23) BHCA27C, 2109072, 754211, 63997844-006 24) BHPM60F, 2109292, 728211, 44353475-005

Distribution pattern

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

device · product 4 of 17

Various PICC Line, Central Line Packs

Z-1692-2022
Recall number
Z-1692-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRPICCLINEH, 2105051, 884211, 14886484 2) UICL44M, 2107142, 807211, 64164800

Distribution pattern

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

device · product 5 of 17

Various ENT Packs

Z-1693-2022
Recall number
Z-1693-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2104262, 887211, 14934943 3) COEN27K, 2108102, 779211, 15093749-004

Distribution pattern

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

device · product 6 of 17

Various Laparoscopy Packs

Z-1694-2022
Recall number
Z-1694-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 7 of 17

Various Cysto Packs

Z-1695-2022
Recall number
Z-1695-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCFHCYTURC, 2105051, 883211, 15142078 2) LSRCFHCYTURC, 2106092, 853211, 44251068 3) LSRCYSTOTURF, 2106181, 834211, 44251068 4) LSRCYSTOTURF, 2108251, 775211, 44376072 5) JECY99B, 2105182, 862211, 44108484-005 6) BHCY71H, 2107011, 819211, 44247051-005 7) SLCY61, 2108111, 777211, 15093750-004 8) BHCY31D, 2107161, 810211, 44228702-005 9) BHCY31D, 2107161, 810211, 44228704-005 10) BHCY31D, 2107161, 810211, 44228703-005 11) BHCY31D, 2109032, 763211, 44333133-005 12) BHCY31D, 2109032, 763211, 44333132-005 13) BHCY31D, 2109032, 763211, 44333131-005 14) BHCY31D, 2109032, 763211, 44333300-005 15) BHCY31D, 2109032, 763211, 44333398-005 16) BHCY31D, 2110051, 726211, 44351428-005 17) BHCY31D, 2110051, 726211, 44351427-005 18) BHCY31D, 2110051, 726211, 44351426-005 19) BHCY31D, 2110051, 726211, 44351425-005 20) UTCY45M, 2104231, 890211, 44175283-005 21) FRCY56D, 2105121, 869211, 44173978-005

Distribution pattern

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

device · product 8 of 17

Various Port Insertion Packs

Z-1696-2022
Recall number
Z-1696-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) GSPI26E, 2108202, 770211, 44336884-005 2) GSPI26E, 2108202, 770211, 44336909-005

Distribution pattern

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

device · product 9 of 17

Breast Abdominoplasty Pack

Z-1697-2022
Recall number
Z-1697-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) SWBA26F, 2106091, 842211, 64133051-006

Distribution pattern

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

device · product 10 of 17

Various convenience packs

Z-1698-2022
Recall number
Z-1698-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
116

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRICUMXBARB, 2104091, 905211, 14531603 2) LSRBASICPACD, 2104091, 90921+A3:A1061, 14798924 3) LSRCFBVIIIPKE, 2104091, 904211, 14806477 4) LSRBASICPACD, 2105101, 881211, 14880418 5) LSRMAJBASINC, 2106082, 860211, 44252207 6) LSRMAJBASINC, 2106082, 860211, 44251930 7) LSRLATEXTUBA, 2106021, 855211, 63157124 8) LSRULTRASNDE, 2106021, 854211, 63157124 9) LSRGCMAJA, 2106082, 852211, 63989104 10) LSRBASICPACD, 2107151, 812211, 15020877 11) LSRBASICPACD, 2107262, 809211, 44540501 12) LSRBASICPACD, 2107262, 809211, 43967223 13) LSRSMTRAMAA, 2107262, 799211, 64117655 14) LSRBASICPACD, 2108042, 791211, 44140770 15) LSRLMMAJLAPI, 2108251, 779211, 64119586 16) LSRMAJBASINC, 2108251, 775211, 44376071 17) LSRBASICPACD, 2109071, 771211, 15142869 18) LSRBASICPACD, 2109071, 771211, 15142870 19) LSRGENLAPD, 2109071, 764211, 44376119 20) LSRGENLAPD, 2109071, 764211, 44376120 21) LSRULTRASNDE, 2109162, 754211, 64318297 22) LSRCFHSBASD, 2109271, 742211, 44373955 23) LSRCFHSBASD, 2109271, 742211, 44373956 24) LSRMAJBASINC, 2109271, 740211, 44373122 25) LSRBASICPACD, 2109271, 740211, 15142071 26) CFLA39E, 2104072, 904211, 64022736 27) IHCO09AC, 2104143, 897211, 64034271 28) IHCO09AC, 2107061, 818211, 64169033 29) TNBS21M, 2108202, 770211, 15065342 30) TNLO05L, 2108193, 770211, 15065666 31) UILT39AB, 2108231, 770211, 64232963 32) UILT39AB, 2108231, 770211, 64232967 33) TNGN04O, 2109072, 755211, 64225628 34) HJMI20F, 2110053, 723211, 15138551 35) SLBS91E, 2104053, 905211, 44127314-005 36) GILA43G, 2104091, 902211, 44126250-005 37) MESB48F, 2104292, 882211, 14877406-004 38) MEGN04T, 2105182, 862211, 44108485-005 39) CXMN85T, 2105202, 861211, 14858002-004 40) MEBS42J, 2105251, 856211, 14858010-004 41) SCSP05Q, 2105272, 853211, 44132237-005 42) MEBS42J, 2106153, 834211, 15002398-004 43) MEBS42J, 2106153, 834211, 15002443-004 44) MEBS42J, 2106153, 834211, 15002445-004 45) MEBS42J, 2106153, 834211, 15002444-004 46) SHMI41H, 2106162, 833211, 43997356-005 47) MHCV01H, 2106221, 827211, 64114273-006 48) MEGN04T, 2106293, 825211, 43993757-005 49) MEGN04T, 2106293, 825211, 43994199-005 50) MEBS42J, 2107121, 810211, 15014941-004 51) PRAB23T, 2107152, 804211, 64100457-006 52) BLBA12J, 2107203, 799211, 15011598-004 53) SLBS91E, 2107202, 800211, 44236721-005 54) SLBS91E, 2107202, 800211, 44236720-005 55) SLBS91E, 2107202, 800211, 44236719-005 56) SLBS91E, 2107202, 800211, 44236717-005 57) SAMN86X, 2107212, 798211, 44236458-005 58) SCSP05Q, 2107211, 799211, 44236716-005 59) CESB24G, 2107221, 798211, 15011356-004 60) BHMB65J, 2107271, 793211, 15009221-004 61) BHMB65J, 2107271, 793211, 15009222-004 62) BHMB65J, 2107271, 793211, 15009223-004 63) FTGS08, 2108161, 775211, 44239258-005 64) ATLO08Y, 2108201, 769211, 44316563-005 65) JESB11F, 2108302, 758211, 15101885-004 66) MEBS42J, 2108303, 768211, 15101887-004 67) BHMN41J, 2109031, 754211, 44313730-005 68) BLBS07H, 2109011, 757211, 15103550-004 69) MEGN04T, 2109082, 749211, 44320301-005 70) SCSP05Q, 2109082, 749211, 44321323-005 71) CXBS22D, 2109101, 760211, 15109750-004 72) SAMN86, 2109133, 744211, 44318760-005 73) GILA43C, 2109151, 742211, 44318759-005 74) JEMJ10N, 2109211, 737211, 64220359-006 75) LMBS30L, 2109232, 735211, 44316978-005 76) BHMN18D, 2104273, 889211, 44189882-005 77) BHMJ56B, 2104281, 884211, 44196650-005 78) BHMJ56B, 2105212, 866211, 44207947-005 79) BHMN18D, 2107061, 819211, n/a 80) UMBR26A, 2108042, 786211, 44217597-005 81) NCMP74H, 2108053, 785211, 64093497-006 82) BHMN18D, 2108091, 783211, 44216491-005 83) BHMN18D, 2108091, 783211, 44336987-005 84) BHMN18D, 2108091, 783211, 44216657-005 85) BHMN18D, 2108091, 783211, 44216490-005 86) TMMN21A, 2108131, 777211, 64093159-006 87) BHMN18D, 2108181, 777211, 44215916-005 88) BHMN18D, 2108231, 769211, 44336910-005 89) BHMN18D, 2108231, 769211, 44334799-005 90) BHMN18D, 2108231, 769211, 44334800-005 91) BHCI35E, 2108271, 769211, 63999572-006 92) BHMJ56B, 2108281, 763211, 44333493-005 93) BHMJ56B, 2108281, 763211, 44333337-005 94) BHMJ56B, 2108281, 763211, 44333491-005 95) BHMN18D, 2108302, 763211, 44333494-005 96) BHMN18D, 2108302, 763211, 44333490-005 97) BHMN18D, 2108302, 763211, 44333495-005 98) BHMN18D, 2108302, 763211, 44333400-005 99) BHMN18D, 2109031, 761211, 44345692-005 100) BHMN18D, 2109031, 761211, 44345693-005 101) BHMN18D, 2109031, 761211, 44332523-005 102) BHMN18D, 2109071, 754211, 44344591-005 103) BHMN18D, 2109071, 754211, 44344590-005 104) BHMN18D, 2109211, 741211, 44356407-005 105) BHMJ56B, 2109281, 740211, 44353431-005 106) SJMB73E, 2105041, 905211, 14703497-004 107) MPMN55C, 2105281, 877211, 14893780-004 108) SFAB10E, 2106071, 847211, 44042725-005 109) MCMJ52D, 2106301, 823211, 44044534-005 110) SAMB25D, 2107011, 819211, 44173648-005 111) SJMB73E, 2107081, 818211, 15032945-004 112) BHSG01B, 2109131, 748211, 64134902-006 113) SAMB25D, 2109131, 750211, 44260252-005 114) SJMB73E, 2109271, 733211, 15023711-006 115) PWBA40H, 2104081, 905211, 14774080-004 116) JRSU11F, 2105261, 861211, 14575286-004

Distribution pattern

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

device · product 11 of 17

Various convenience packs

Z-1699-2022
Recall number
Z-1699-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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

device · product 12 of 17

Various neurology packs

Z-1700-2022
Recall number
Z-1700-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
37 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRLMNEINTC, 2105181, 870211, 63990989 2) LSRSWRSPNC, 2105251, 861211, 63990357 3) LSRLMNEUROG, 2106161, 845211, 44139500 4) LSRSMHNEURE, 2108101, 793211, 44139500 5) LSRNEURCRANIH, 2108171, 776211, 64123199 6) LSRLMNEUROG, 2110011, 730211, 64316283 7) UINR44M, 2104162, 896211, 64033036 8) TNNE17Y, 2109081, 750211, 64224067 9) SLCR80E, 2104262, 884211, 63986071-006 10) GISP04A, 2104293, 881211, 63985242-006 11) FHNE25Y, 2107083, 811211, 64110740-006 12) BHLA24L, 2108253, 763211, 64205048-006 13) CBAC47F, 2109092, 749211, 64209378-006 14) SLCN72B, 2109161, 741211, 64208359-006 15) BHCR54D, 2104132, 901211, 64072795-006 16) BHCR54D, 2104132, 901211, 64072796-006 17) BHCR54D, 2104132, 901211, 64072273-006 18) BHLM30D, 2105111, 874211, 64062457-006 19) BHCR54D, 2105252, 861211, 64063353-006 20) BHLM30D, 2107091, 819211, 64088774-006 21) BHLM30D, 2107091, 819211, 64088775-006 22) BHLM30D, 2107091, 819211, 64088776-006 23) BHCR54D, 2107161, 810211, 64088824-006 24) BHCR54D, 2107161, 810211, 64088823-006 25) BHLM30D, 2108202, 770211, 64001247-006 26) BHLM30D, 2108202, 770211, 64001248-006 27) BHLM30D, 2108202, 770211, 64001249-006 28) BHLM30D, 2108202, 770211, 64001250-006 29) BHCR54D, 2109022, 757211, 63998620-006 30) BHCR54D, 2109022, 757211, 63998619-006 31) BHCR54D, 2109022, 757211, 63998618-006 32) UMNA22B, 2109292, 728211, 64310294-006 33) DVSP33E, 2104302, 884211, 64064626-006 34) MCSP61F, 2107021, 819211, 64128815-006 35) SJSC27F, 2107091, 813211, 44173743-005 36) SANE32G, 2108091, 784211, 44170921-005 37) MCSP61F, 2108091, 785211, 64138850-006

Distribution pattern

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

device · product 13 of 17

Various ob/gyn packs

Z-1701-2022
Recall number
Z-1701-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSROBDELIVC, 2104091, 904211, 14531604 2) LSRVAGDELIVC, 2106011, 863211, 44252284 3) LSRVAGDELIVC, 2106011, 863211, 44135283 4) LSRCFHVAGDC, 2108042, 791211, 64123598 5) LSRCFHVAGDC, 2108042, 791211, 64123599 6) LSRCFHVAGDC, 2108042, 791211, 64123597 7) LSRVAGDELIVC, 2108181, 776211, 44139780 8) LSROBDELIVC, 2109231, 743211, 64319309 9) UPVD01G, 2109211, 741211, 15187693 10) MEVG08P, 2105132, 873211, 14874335-004 11) SLOB77F, 2108101, 779211, 15093748-004 12) MEVG08Q, 2108192, 770211, 15103947-004 13) BHVG89C, 2104291, 887211, 14962314-004 14) BHVG89C, 2106303, 827211, 14956518-004 15) AGOB35D, 2107221, 799211, 64183198-006

Distribution pattern

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

device · product 14 of 17

Various hysterectomy, vaginal packs

Z-1702-2022
Recall number
Z-1702-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRGYOSCOPYG, 2104281, 888211, 63995389 2) LSRLMGLAPF, 2105282, 856211, 44252282 3) LSRHPGYND, 2106092, 847211, 14887375 4) LSRHPGYND, 2106092, 847211, 14887374 5) LSRHPGYND, 2106092, 847211, 14887373 6) AMJL22Z, 2106112, 840211, 64176443 7) FDMN88N, 2107013, 821211, 64168939 8) MMJL16C, 2108023, 791211, 44180974 9) UIGY37AA, 2108033, 789211, 64104498 10) FHGG12V, 2109131, 748211, 64223133 11) BHOB33G, 2104191, 894211, 14870011-004 12) AHHY33M, 2105131, 867211, 14874336-004 13) MEHY02M, 2106152, 834211, 15003746-004 14) MEHY02M, 2106152, 834211, 15003740-004 15) MEHY02M, 2106152, 834211, 15003713-004 16) MEHY02M, 2106152, 834211, 15003709-004 17) MEHY02M, 2106152, 834211, 15003704-004 18) MEHY02M, 2106152, 834211, 15001377-004 19) MEHY02M, 2106152, 834211, 15003712-004 20) CXVG89X, 2106171, 833211, 43996010-005 21) SLGG63G, 2106282, 821211, 64071565-006 22) BHVR88A, 2106291, 828211, 64090094-006 23) UMVG16A, 2109031, 756211, 63998597-006 24) BHVP17H, 2106071, 845211, 14901608-004 25) BHVP17H, 2106071, 845211, 14901609-004 26) BHVP17H, 2108051, 785211, 15028595-004 27) BHVP17H, 2109031, 755211, 15023691-004 28) MCGY26E, 2109071, 754211, 44261563-005 29) MPGY64E, 2109081, 754211, 44261561-005

Distribution pattern

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

device · product 15 of 17

Various C-section packs

Z-1703-2022
Recall number
Z-1703-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPCSECTB, 2106301, 826211, 64124711 2) FHCP08U, 2107143, 807211, 64166455 3) LMSE38N, 2108202, 770211, 64231900 4) CFCS39G, 2108243, 768211, 64232041 5) IHCS29AA, 2109272, 733211, 64214921 6) CXCS92U, 2106191, 830211, 64071586-006 7) BHCS88D, 2104163, 897211, 64072275-006 8) BHCS88D, 2104163, 897211, 64072274-006 9) BHCS88D, 2104163, 897211, 64072275-006 10) BHCS88D, 2105151, 869211, 64067191-006 11) BHCS88D, 2106091, 848211, 64045555-006 12) BHCS88D, 2106232, 835211, 64091025-006 13) BHCS88D, 2106232, 835211, 64091024-006 14) BHCS88D, 2107061, 835211, 64090343-006 15) BHCS88D, 2107132, 811211, 64089826-006 16) BHCS88D, 2107132, 811211, 64089827-006 17) BHCS88D, 2107132, 811211, 64089828-006 18) BHCS88D, 2107161, 806211, 64088821-006 19) BHCS88D, 2107161, 806211, 64088822-006 20) BHCS88D, 2108171, 777211, 64092742-006 21) BHCS88D, 2109072, 758211, 63997845-006 22) BHCS88D, 2109072, 758211, 63997846-006 23) SWCS92K, 2107151, 811211, 64129480-006 24) SSCS25D, 2108171, 774211, 64139013-006

Distribution pattern

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

device · product 16 of 17

D&C pack

Z-1704-2022
Recall number
Z-1704-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LLDC40G, 2108101, 785211, 44272963-005

Distribution pattern

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

device · product 17 of 17

Various eye packs, cataract packs

Z-1705-2022
Recall number
Z-1705-2022
Initiated
June 16, 2022
Classification
Class II
Status
Ongoing
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was exposed to multiple sterilization cycles without validation for multiple exposures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) BLSE37K, 2106292, 820211, 15017475-004 2) MECA21P, 2108022, 786211, 44234851-005 3) CMEY17AD, 2108301, 760211, 15101886-004 4) CXEY80X, 2109083, 749211, 15109749-004

Distribution pattern

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