The Recall Desk
HighFDA (Devices)·Z-0184-2026·Announced 2025-10-22

Orthopedic procedure packs recalled after being sterilized more than once

American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.

Plain-English summary

Medical convenience kits used in orthopedic procedures are being recalled. Affected item numbers include ANSH14AF (Shoulder Pack), EVAH76H (Anterior Hip Pack), FDSA15M (Shoulder Arthroscopy), GRTS90G (Total Shoulder Pack), HGHI26G (Hip Pinning Pack), HJTO25C (Total Hip Accessory Pack) and HNEX60L (Extremity Pack).

The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.

The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.

Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.

The recalled product

Product
Medical 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 IAS
Manufacturer
American Contract Systems Inc.
Category
Medical Device — Surgical kit
Hazard
  • resterilization
  • unvalidated-process
  • sterility-assurance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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