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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems

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 Class 2 Device Recall American Contract Systemssee related information
Date Initiated by FirmSeptember 04, 2025
Date PostedOctober 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0184-2026
Recall Event ID 97659
Product Classification Orthopedic tray - Product Code OJH
ProductMedical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
Code Information AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A; ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192; EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760; FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299; GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A; HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A; HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159; HNEX60L 191072193643 lot 8487711 bag serial number 68641794; IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092; IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A; IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A; ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822; LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A; LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A; MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A; MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A; MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A; MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A; PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107; RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959; TSTH54D UDI-DI 191072229878 lot 8411811 bag serial number 68666214; UDEX85Y UDI-DI 191072216267 lot 8047611 bag serial number N/A; UDHD69U UDI-DI 191072216298 lot 7991811 bag serial number 17402072; UDKN68AH UDI-DI 191072226013 lot 8046511 bag serial number 68045970; UIHN18AW UDI-DI 191072228956 lot 8025311 bag serial number 68153870; UIHN18AX UDI-DI 191072234049 lot 8192211 bag serial number 68195746; UIKN28AR UDI-DI 191072228970 lot 8049011 bag serial number 68135550; UISO44I UDI-DI 191072205407 lot 8027311 bag serial number 68153822 * If bag serial number is listed as "N/A", then whole lot is affected
Recalling Firm/
Manufacturer		 American Contract Systems Inc.
1601 Se Gateway Dr Ste 120
Grimes IA 50111-5223
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer Reason
for Recall		Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Quantity in Commerce32,433 total
DistributionUS Nationwide distribution in the states of SD, IA, MN, WA, IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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