Reported Oct 22, 2025 · Ongoing

Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M…

American Contract Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223

Is this the product you have?

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 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)

Lot codes and dates: 28 of 28 products
Products covered by this recall
# Barcodes Product as published
1 191072207340 AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A
2 00191072214461 ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192
3 191072221858 EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760
4 191072185396 FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299
5 191072208262 GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A
6 191072212559 HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A
7 191072105684 HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159
8 191072193643 HNEX60L 191072193643 lot 8487711 bag serial number 68641794
9 191072232564 IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092
10 191072224477 IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A
11 191072234100 IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A
12 197012208279 ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822
13 191072202932 LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A
14 191072236265 LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A
15 191072214983 MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A
16 191072216120 MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A
17 191072208538 MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A
18 191072225344 MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A
19 191072225740 PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107
20 191072226266 RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959
Page 1 of 2
Amount recalled: 32,433 total

This recall covers 18 products

The agency filed one notice per product. You are reading one of them; the other 17 are below.

5 more are in the archive.

Where it was sold

Nationwide
SD
IA
MN
WA
IL

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`191072207340`	AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A
2	`00191072214461`	ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192
3	`191072221858`	EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760
4	`191072185396`	FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299
5	`191072208262`	GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A
6	`191072212559`	HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A
7	`191072105684`	HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159
8	`191072193643`	HNEX60L 191072193643 lot 8487711 bag serial number 68641794
9	`191072232564`	IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092
10	`191072224477`	IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A
11	`191072234100`	IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A
12	`197012208279`	ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822
13	`191072202932`	LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A
14	`191072236265`	LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A
15	`191072214983`	MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A
16	`191072216120`	MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A
17	`191072208538`	MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A
18	`191072225344`	MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A
19	`191072225740`	PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107
20	`191072226266`	RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959