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American Contract Systems Inc

FDA Regulatory Profile

American Contract Systems Inc has 213 FDA recalls (3 Class I), 38 inspections, 0 510(k) clearances and 4 compliance actions on record.

Latest recall
Z-3294-2026 · Class II · Aug 10, 2026
Latest inspection
Jun 2, 2025 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls213 (3 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections38Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions4Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
Z-3294-2026Class IIMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays…Aug 10, 2026
Z-3292-2026Class IIMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays…Aug 10, 2026
Z-3293-2026Class IIMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays…Aug 10, 2026
Z-3001-2026Class IIAmerican Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANJun 29, 2026
Z-3000-2026Class IIAmerican Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMJun 29, 2026
Z-3002-2026Class IIAmerican Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APJun 29, 2026
Z-3003-2026Class IIAmerican Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HJun 29, 2026
Z-2989-2026Class IIAmerican Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400…May 19, 2026
Z-2990-2026Class IIAmerican Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK…May 19, 2026
Z-1981-2026Class IConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor…Mar 19, 2026
Z-0171-2026Class IIBasic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY…Sep 4, 2025
Z-0175-2026Class IIMedical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB…Sep 4, 2025
Z-0187-2026Class IIMedical convenience kits IHDC30R D AND C PACKSep 4, 2025
Z-0180-2026Class IIMedical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK…Sep 4, 2025
Z-0170-2026Class IIBasic Biopsy Tray, Item Number NMBP44LSep 4, 2025
Z-0177-2026Class IIMedical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY…Sep 4, 2025
Z-0184-2026Class IIMedical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962…Sep 4, 2025
Z-0182-2026Class IIMedical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKSep 4, 2025
Z-0185-2026Class IIMedical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE…Sep 4, 2025
Z-0183-2026Class IIMedical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY…Sep 4, 2025

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 2, 2025Tiffin, OHDevicesOfficial Action Indicated (OAI)3008492337
Apr 17, 2025Temple Terrace, FLDevicesNo Action Indicated (NAI)3003309947
Mar 21, 2025Fort Myers, FLDevicesVoluntary Action Indicated (VAI)3010052743
Jan 16, 2025Grimes, IADevicesNo Action Indicated (NAI)3007069947
Aug 14, 2024Tiffin, OHDevicesOfficial Action Indicated (OAI)3008492337
Apr 8, 2022Temple Terrace, FLDevicesNo Action Indicated (NAI)3003309947
Mar 25, 2022Zelienople, PADevicesNo Action Indicated (NAI)3011389083
Mar 2, 2022Kansas City, MODevicesVoluntary Action Indicated (VAI)3003419114
Dec 8, 2021Fort Myers, FLDevicesVoluntary Action Indicated (VAI)3010052743
Dec 7, 2021Riverside, CADevicesNo Action Indicated (NAI)3016444870
Dec 3, 2021Chandler, AZDevicesNo Action Indicated (NAI)3010126341
Sep 24, 2021Grimes, IADevicesVoluntary Action Indicated (VAI)3007069947
Oct 4, 2019Houston, TXDevicesOfficial Action Indicated (OAI)3009189894
Sep 10, 2019Kansas City, MODevicesNo Action Indicated (NAI)3003419114
Aug 16, 2019Temple Terrace, FLDevicesNo Action Indicated (NAI)3003309947
Jul 25, 2019Zelienople, PADevicesOfficial Action Indicated (OAI)3011389083
Apr 1, 2019Chandler, AZDevicesNo Action Indicated (NAI)3010126341
Oct 2, 2018Zelienople, PADevicesOfficial Action Indicated (OAI)3011389083
May 24, 2018Kansas City, MODevicesVoluntary Action Indicated (VAI)3003419114
Jul 26, 2017Fort Myers, FLDevicesNo Action Indicated (NAI)3010052743

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3008492337Tiffin, OH5Jun 2, 2025
FEI 3003309947Temple Terrace, FL5Apr 17, 2025
FEI 3010052743Fort Myers, FL3Mar 21, 2025
FEI 3007069947Grimes, IA4Jan 16, 2025
FEI 3011389083Zelienople, PA5Mar 25, 2022
FEI 3003419114Kansas City, MO6Mar 2, 2022
FEI 3016444870Riverside, CA1Dec 7, 2021
FEI 3010126341Chandler, AZ2Dec 3, 2021
FEI 3009189894Houston, TX2Oct 4, 2019
FEI 3003368406Waunakee, WI3May 11, 2017
FEI 3008493588Chesapeake, VA2Jan 9, 2014

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.