FDA recall record · openFDA
American Contract Systems Inc
162 FDA recalls on record (2023–2026) — 162 device. 162 still ongoing.
1
Class I (most serious)
160
Class II
1
Class III
162
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for 39
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality m 32
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the contr 19
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected t 18
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethyle 18
Recalls
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo Class I 2026-03-19 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4 Class II 2025-07-14 MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02 Class II 2025-02-06 Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Sof Class II 2025-01-31 LABOR & DELIVERY PACK, Model Nos LLLD19H Class II 2025-02-06 CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 Class II 2025-02-06 GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 Class II 2025-02-06 Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN Class II 2025-09-04 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLB Class II 2025-07-14 C-SECTION PACK, Model Nos LLCS44F LLCS44F-01 Class II 2025-02-06 DIAGNOSTIC NEURO IR TRAY , Model No WENE21 Class II 2025-02-06 DELIVERY PACK , Model No SGDV22D-01 SGDV22E Class II 2025-02-06 OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I Class II 2025-02-06 Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17 Class II 2025-09-04 Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC Class II 2025-09-04 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NU Class II 2025-07-14 HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 Class II 2025-02-06 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B Class II 2025-02-06 LAPAROSCOPY PACK , Model No SFLA02A SFLA02B Class II 2025-02-06 CYSTO , Model No SACY80R Class II 2025-02-06 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANC Class II 2025-07-14 DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 Class II 2025-02-06 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Class II 2025-07-14 LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 Class II 2025-02-06 Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DEL Class II 2025-09-04 CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. Class II 2025-02-04 Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni Class II 2025-01-31 VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 Class II 2025-02-06 Medical convenience kits IHDC30R D AND C PACK Class II 2025-09-04 Basic Biopsy Tray, Item Number NMBP44L Class II 2025-09-04 CYSTO PACK , Model N. HKCY31A Class II 2025-02-06 BORN ON ARRIVAL KIT , Model No LLBN11B Class II 2025-02-06 URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 Class II 2025-02-06 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; Class II 2025-07-14 GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 Class II 2025-02-06 C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 Class II 2025-02-06 Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15 Class II 2025-09-04 AV FISTULA , Model No UTAV77T Class II 2025-02-06 THORACIC PACK , Model No UTTC82Y UTTC82AA-01 Class II 2025-02-06 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61 Class II 2025-07-14 Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC Class II 2025-09-04 OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 Class II 2025-02-06 CV BASIC PUMP PACK , Model No WECV23D Class II 2025-02-06 Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 Class II 2025-09-04 Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK Class II 2025-09-04 Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH Class II 2025-09-04 Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BA Class II 2025-09-04 Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASI Class II 2025-09-04 MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H Class II 2025-02-06 SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB Class II 2025-02-06 NEURO IR TRAY , Model No WENI56J Class II 2025-02-06 Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PAC Class II 2025-09-04 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYS Class II 2025-07-14 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B Class II 2025-02-06 EAR PACK , Model No SFEA12A Class II 2025-02-06 LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02 Class II 2025-02-06 Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Class II 2025-01-31 Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCN Class II 2025-09-04 Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951 Class II 2025-09-04 LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G Class II 2025-02-06 Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CEN Class II 2025-09-04 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E Class II 2025-07-14 LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Class II 2025-04-21 TOTAL HIP PACK , Model No SMTH06O SMTH06P Class II 2025-02-06 Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY Class II 2025-09-04 TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF Class II 2024-05-15 Pacemaker, COPM11B; Medical convenience kit Class II 2024-08-07 UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG Class II 2024-05-15 HAND PACK-Procedure Kit Catalog Number: WEHD16B Class II 2024-05-15 ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A Class II 2024-05-15 ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C Class II 2024-05-15 Hand Pack, AKHD97C; Medical convenience kit Class II 2024-08-07 Vaginal Delivery, ASDV25B; Medical convenience kit Class II 2024-08-07 IR Procedure Pack, CEAT19W; Medical convenience kit Class II 2024-08-07 TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E Class II 2024-05-15 HAND PACK-Procedure Kit Catalog Number: WEHD16C Class II 2024-05-15 Nasal Sinus Pack, MTSN26B; Medical convenience kit Class II 2024-08-07 KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G Class II 2024-05-15 KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A Class II 2024-05-15 PACEMAKER PACK, SLCV01J; Medical convenience kit Class II 2024-08-07 Neuro Vascular, ANKV91A; Medical convenience kit Class II 2024-08-07 TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z Class II 2024-05-15 Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit Class II 2024-08-07 HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F Class II 2024-05-15 KNEE SCOPE Procedure tray Catalog Number: COKN48L Class II 2024-05-15 TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A Class II 2024-05-15 TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP Class II 2024-05-15 ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B Class II 2024-05-15 HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B Class II 2024-05-15 Paracentesis Thoracente, SLPT76H; Medical convenience kit Class II 2024-08-07 AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K Class II 2024-05-15 Cath Lab Pack, CECL02P; Medical convenience kit Class II 2024-08-07 American Contract Systems Spine Pack convenience kit Class II 2024-05-06 Endovascular AAA Pack, ESED52B; Medical convenience kit Class II 2024-08-07 TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA Class II 2024-05-15 CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG Class II 2024-05-15 Shoulder, SESH18I; Medical convenience kit Class II 2024-08-07 TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B Class II 2024-05-15 TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L Class II 2024-05-15 BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C Class II 2024-05-15 American Contract Systems Hand Pack convenience kit Class II 2024-05-06 American Contract Systems Biopsy Drape Pack convenience kit Class II 2024-05-06 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U Class II 2024-05-15 Cysto, FTCY03L; Medical convenience kit Class II 2024-08-07 ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B Class II 2024-05-15 ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA Class II 2024-05-15 TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C Class II 2024-05-15 KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R Class II 2024-05-15 MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B Class II 2024-05-15 ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S Class II 2024-05-15 Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit Class II 2024-08-07 Day Surgery General Pack, FHGE18T; Medical convenience kit Class II 2024-08-07 CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE Class II 2024-05-15 Endovascular AAA Pack, ESED52B; Medical convenience kit Class II 2024-08-07 TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K Class II 2024-05-15 FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B Class II 2024-05-15 American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience Class II 2024-05-06 TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B Class II 2024-05-15 American Contract Systems Special Procedure Pack convenience kit Class II 2024-05-06 LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X Class II 2024-05-15 American Contract Systems Cataract Pack convenience kit Class II 2024-05-06 American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American C Class II 2024-05-06 ENT, COEN27N; Medical convenience kit Class II 2024-08-07 ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V Class II 2024-05-15 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B Class II 2024-05-15 American Contract Systems Gyn Laparoscopy convenience kit Class II 2024-05-06 Arthroscopy Pack, MSKA45A; Medical convenience kit Class II 2024-08-07 ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA Class II 2024-05-15 HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I Class II 2024-05-15 KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A Class II 2024-05-15 Open Shoulder, LWOS39L; Medical convenience kit Class II 2024-08-07 LAVH, REF BBLV21C Class II 2023-09-01 Robotics Pack SAH, REF SAR530M Class II 2023-09-01 Robotics Pack, REF SJVO56B Class II 2023-09-01 Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB Class II 2023-11-29 Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGT Class II 2023-11-29 Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21 Class II 2023-11-29 Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; Class II 2023-11-29 Vasc. Open CVOR SJH, REF SJVO56B Class II 2023-09-01 Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, Class II 2023-11-29 CVS PCSU SJH, REF SJCV48J Class II 2023-09-01 Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit Class II 2023-11-29 Pediatric Heart SJH, REF SJPH34K Class II 2023-09-01 Cath Cardiac Pack, REF IHCC03V Class II 2023-09-01 Robotics Pack, REF SSRO22D Class II 2023-09-01 Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; Class II 2023-11-29 Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit Class II 2023-11-29 Sub Q Recorder Pack, REF BPRC87A Class II 2023-09-01 Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit num Class II 2023-11-29 Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; Class II 2023-11-29 Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; Class II 2023-11-29 Breast Plastics Pack, REF BBPL20D Class II 2023-09-01 Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit n Class II 2023-11-29 Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit num Class II 2023-11-29 Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, Class II 2023-11-29 Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; Class II 2023-11-29 Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA0 Class II 2023-11-29 Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Lamine Class II 2023-11-29 Pediatric Urology Wolson Pack, REF BPPU55A Class II 2023-09-01 General Pack, REF BBGP31C Class II 2023-09-01 Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HI Class II 2023-11-29 Total Knee Pack, REF CETJ130, medical convenience kits Class III 2023-04-17
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.