American Contract Systems Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 204 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 38
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1981-2026 | Class I | Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor COR | March 19, 2026 |
| Z-0173-2026 | Class II | Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 | September 4, 2025 |
| Z-0176-2026 | Class II | Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET U | September 4, 2025 |
| Z-0174-2026 | Class II | Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 20597 | September 4, 2025 |
| Z-0184-2026 | Class II | Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTER | September 4, 2025 |
| Z-0182-2026 | Class II | Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK | September 4, 2025 |
| Z-0171-2026 | Class II | Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANL | September 4, 2025 |
| Z-0180-2026 | Class II | Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK | September 4, 2025 |
| Z-0175-2026 | Class II | Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB | September 4, 2025 |
| Z-0186-2026 | Class II | Medical convenience kits UDPG88W PICC G-TUBE PACK-230209 | September 4, 2025 |
| Z-0172-2026 | Class II | Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST | September 4, 2025 |
| Z-0181-2026 | Class II | Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK | September 4, 2025 |
| Z-0187-2026 | Class II | Medical convenience kits IHDC30R D AND C PACK | September 4, 2025 |
| Z-0179-2026 | Class II | Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M G | September 4, 2025 |
| Z-0185-2026 | Class II | Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE P | September 4, 2025 |
| Z-0183-2026 | Class II | Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY P | September 4, 2025 |
| Z-0178-2026 | Class II | Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NEC | September 4, 2025 |
| Z-0177-2026 | Class II | Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KI | September 4, 2025 |
| Z-0170-2026 | Class II | Basic Biopsy Tray, Item Number NMBP44L | September 4, 2025 |
| Z-2472-2025 | Class II | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MOD | July 14, 2025 |