FDA Device Recalls

Recalls / Firms / American Contract Systems Inc.

American Contract Systems Inc.

189 FDA device recalls on record.

DateClassProductReason
2025-09-04Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK
2025-09-04Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 20597
2025-09-04Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M G
2025-09-04Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB
2025-09-04Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK
2025-09-04Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KI
2025-09-04Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
2025-09-04Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NEC
2025-09-04Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE P
2025-09-04Medical convenience kits IHDC30R D AND C PACK
2025-09-04Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387
2025-09-04Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTER
2025-09-04Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY P
2025-09-04Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANL
2025-09-04Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET U
2025-09-04Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
2025-09-04Basic Biopsy Tray, Item Number NMBP44L
2025-09-04Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Numb
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, M
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODE
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK -
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 13
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, M
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MOD
2025-07-14AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/
2025-04-21LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K
2025-02-06MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
2025-02-06LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
2025-02-06BORN ON ARRIVAL KIT , Model No LLBN11B
2025-02-06URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
2025-02-06OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
2025-02-06AV FISTULA , Model No UTAV77T
2025-02-06EAR PACK , Model No SFEA12A
2025-02-06DELIVERY PACK , Model No SGDV22D-01 SGDV22E
2025-02-06VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
2025-02-06DIAGNOSTIC NEURO IR TRAY , Model No WENE21
2025-02-06OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
2025-02-06CYSTO , Model No SACY80R
2025-02-06LABOR & DELIVERY PACK, Model Nos LLLD19H
2025-02-06LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
2025-02-06THORACIC PACK , Model No UTTC82Y UTTC82AA-01
2025-02-06DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
2025-02-06CV BASIC PUMP PACK , Model No WECV23D
2025-02-06TOTAL HIP PACK , Model No SMTH06O SMTH06P
2025-02-06LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
2025-02-06LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
2025-02-06NEURO IR TRAY , Model No WENI56J
2025-02-06C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
2025-02-06CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
2025-02-06LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
2025-02-06C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
2025-02-06MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
2025-02-06GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
2025-02-06GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
2025-02-06SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
2025-02-06LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
2025-02-06CYSTO PACK , Model N. HKCY31A
2025-02-06HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
2025-02-04CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
2025-01-31Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog
2025-01-31Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H S
2025-01-31Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product
2024-08-07IR Procedure Pack, CEAT19W; Medical convenience kit
2024-08-07Neuro Vascular, ANKV91A; Medical convenience kit
2024-08-07Cath Lab Pack, CECL02P; Medical convenience kit
2024-08-07ENT, COEN27N; Medical convenience kit
2024-08-07Nasal Sinus Pack, MTSN26B; Medical convenience kit
2024-08-07Endovascular AAA Pack, ESED52B; Medical convenience kit
2024-08-07Arthroscopy Pack, MSKA45A; Medical convenience kit
2024-08-07Open Shoulder, LWOS39L; Medical convenience kit
2024-08-07Pacemaker, COPM11B; Medical convenience kit
2024-08-07Shoulder, SESH18I; Medical convenience kit
2024-08-07Hand Pack, AKHD97C; Medical convenience kit
2024-08-07Paracentesis Thoracente, SLPT76H; Medical convenience kit
2024-08-07Vaginal Delivery, ASDV25B; Medical convenience kit
2024-08-07PACEMAKER PACK, SLCV01J; Medical convenience kit
2024-08-07Cysto, FTCY03L; Medical convenience kit
2024-08-07Endovascular AAA Pack, ESED52B; Medical convenience kit
2024-08-07Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
2024-08-07Day Surgery General Pack, FHGE18T; Medical convenience kit
2024-08-07Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
2024-05-15TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
2024-05-15ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
2024-05-15LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
2024-05-15ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
2024-05-15CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
2024-05-15ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
2024-05-15ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
2024-05-15HAND PACK-Procedure Kit Catalog Number: WEHD16B
2024-05-15TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
2024-05-15BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
2024-05-15TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
2024-05-15KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
2024-05-15TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
2024-05-15ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
2024-05-15ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
2024-05-15CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
2024-05-15TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
2024-05-15KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
2024-05-15TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
2024-05-15KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
2024-05-15AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
2024-05-15ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
2024-05-15HAND PACK-Procedure Kit Catalog Number: WEHD16C
2024-05-15MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
2024-05-15HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
2024-05-15TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
2024-05-15TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
2024-05-15ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
2024-05-15ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
2024-05-15KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
2024-05-15TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
2024-05-15UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
2024-05-15KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
2024-05-15TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
2024-05-15FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
2024-05-15HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
2024-05-15TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
2024-05-15KNEE SCOPE Procedure tray Catalog Number: COKN48L
2024-05-15HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
2024-05-06American Contract Systems Spine Pack convenience kit
2024-05-06American Contract Systems Hand Pack convenience kit
2024-05-06American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems L
2024-05-06American Contract Systems Biopsy Drape Pack convenience kit
2024-05-06American Contract Systems Gyn Laparoscopy convenience kit
2024-05-06American Contract Systems Special Procedure Pack convenience kit
2024-05-06American Contract Systems Cataract Pack convenience kit
2024-05-06American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience
2023-11-29Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Pla
2023-11-29Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP
2023-11-29Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THE
2023-11-29Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABO
2023-11-29Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH
2023-11-29Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit,
2023-11-29Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK,
2023-11-29Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SE
2023-11-29Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BI
2023-11-29Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWE
2023-11-29Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit
2023-11-29Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK,
2023-11-29Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY,
2023-11-29Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit numbe
2023-11-29Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number
2023-11-29Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH
2023-11-29Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE N
2023-11-29Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit numb
2023-09-01Robotics Pack, REF SSRO22D
2023-09-01CVS PCSU SJH, REF SJCV48J
2023-09-01Pediatric Heart SJH, REF SJPH34K
2023-09-01Breast Plastics Pack, REF BBPL20D
2023-09-01Robotics Pack SAH, REF SAR530M
2023-09-01Pediatric Urology Wolson Pack, REF BPPU55A
2023-09-01Vasc. Open CVOR SJH, REF SJVO56B
2023-09-01General Pack, REF BBGP31C
2023-09-01Cath Cardiac Pack, REF IHCC03V
2023-09-01LAVH, REF BBLV21C
2023-09-01Robotics Pack, REF SJVO56B
2023-09-01Sub Q Recorder Pack, REF BPRC87A
2023-04-17Total Knee Pack, REF CETJ130, medical convenience kits
2022-10-12BASIN SET, MEBS42K, general surgical kit
2022-08-12COVID Test Kit Nonsterile
2022-06-16Various convenience packs
2022-06-16Various Angiography/Cath Lab packs/trays
2022-06-16Various Pacemaker Packs, Cardio Thoracic Packs
2022-06-16Various neurology packs
2022-06-16D&C pack
2022-06-16Various Cysto Packs
2022-06-16Various eye packs, cataract packs
2022-06-16Various hysterectomy, vaginal packs
2022-06-16Various C-section packs
2022-06-16Various PICC Line, Central Line Packs
2022-06-16Various ob/gyn packs
2022-06-16Various ENT Packs
2022-06-16Various convenience packs
2022-06-16Various Port Insertion Packs
2022-06-16Various Angiography packs/trays
2022-06-16Breast Abdominoplasty Pack
2022-06-16Various Laparoscopy Packs
2022-05-02Clean Catch Urine Kit NS 178489, AHMU58A
2022-05-02Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184
2022-03-22ACS IR - Angio Pack
2022-03-221) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
2022-03-22ACS Cath Lab Pack
2022-03-221) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
2022-03-22ACS Lap Chole Pack
2018-11-21Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following:
2016-12-28Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powder