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American Contract Systems, Inc.
American Contract Systems, Inc.: 190 FDA recall reports
Every medical device recall the FDA has published for American Contract Systems, Inc.. The fault, and how the agency graded it.
190Reports
3Class I
187Ongoing
2026-05-13Most recent
3 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGI
Z-1981-2026 · Class I · reported 2026-05-13 · Ongoing
- Why it was recalled
- Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
- Product
- Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
- Where it went
- US distribution to MN. No OUS distribution.
- How much
- 7,311 kits
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK C
Z-0180-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 2131
Z-0185-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y
Z-0174-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B V
Z-0173-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits IHDC30R D AND C PACK
Z-0187-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits IHDC30R D AND C PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Basic Biopsy Tray, Item Number NMBP44L
Z-0170-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Basic Biopsy Tray, Item Number NMBP44L
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PA
Z-0184-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- 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 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)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP
Z-0171-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Z-0186-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Z-0182-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IH
Z-0175-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-
Z-0181-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANB
Z-0172-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MH
Z-0176-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 20
Z-0183-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246
Z-0178-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R
Z-0177-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907
Z-0179-2026 · Class II · reported 2025-10-22 · Ongoing
- 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.
- Product
- Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
- Where it went
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- How much
- 32,433 total
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NU
Z-2472-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.
- Where it went
- US distribution to states of: IL and LA
- How much
- 588 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item
Z-2469-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
- Where it went
- US distribution to states of: IL and LA
- How much
- 781 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MOD
Z-2468-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
- Where it went
- US distribution to states of: IL and LA
- How much
- 204 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM
Z-2464-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F; 6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G; 7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F; 8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K; 9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H; 10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM; 11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D; 12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C; 13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G; 14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T; 15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM; 16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD; 17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF; 18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH; 19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN; 20) SFCH PEDS...
- Where it went
- US distribution to states of: IL and LA
- How much
- 31506 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, M
Z-2467-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
- Where it went
- US distribution to states of: IL and LA
- How much
- 6617 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Numbe
Z-2465-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;
- Where it went
- US distribution to states of: IL and LA
- How much
- 1233 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUM
Z-2470-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
- Where it went
- US distribution to states of: IL and LA
- How much
- 1094 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A
Z-2466-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.
- Where it went
- US distribution to states of: IL and LA
- How much
- 1127 units
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMB
Z-2471-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
- Where it went
- US distribution to states of: IL and LA
- How much
- 50 units
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL K
Z-1916-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
- Product
- LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
- Where it went
- US Nationwide distribution in the state of CO.
- How much
- 850 Kits
Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GS
Z-1426-2025 · Class II · reported 2025-04-02 · Ongoing
- Why it was recalled
- Sterility assurance with procedure trays
- Product
- Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
- Where it went
- US: AZ OUS: None
- How much
- 460 kits.
Showing the 30 most recent of 190. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls