Customed, Inc
FDA Regulatory Profile
Customed, Inc appears in FDA public data with 682 recalls — including 412 Class I (most serious) —, 37 510(k) clearances, 9 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1436-2016, Class II) was initiated on January 7, 2016. Its most recent 510(k) clearance was granted on June 3, 2026.
Summary
- Total Recalls
- 682 (412 Class I)
- 510(k) Clearances
- 37
- Inspections
- 9
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1436-2016 | Class II | Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedure | January 7, 2016 |
| Z-1483-2016 | Class II | Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedure | January 7, 2016 |
| Z-1443-2016 | Class II | Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical proced | January 7, 2016 |
| Z-1446-2016 | Class II | Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures a | January 7, 2016 |
| Z-1457-2016 | Class II | Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and p | January 7, 2016 |
| Z-1442-2016 | Class II | Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedure | January 7, 2016 |
| Z-1488-2016 | Class II | Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical proc | January 7, 2016 |
| Z-1482-2016 | Class II | Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical proc | January 7, 2016 |
| Z-1397-2016 | Class II | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedu | January 7, 2016 |
| Z-1417-2016 | Class II | Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedure | January 7, 2016 |
| Z-1441-2016 | Class II | Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical | January 7, 2016 |
| Z-1407-2016 | Class II | Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedur | January 7, 2016 |
| Z-1491-2016 | Class II | Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedur | January 7, 2016 |
| Z-1422-2016 | Class II | Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures | January 7, 2016 |
| Z-1413-2016 | Class II | Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical | January 7, 2016 |
| Z-1475-2016 | Class II | Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Us | January 7, 2016 |
| Z-1425-2016 | Class II | Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgi | January 7, 2016 |
| Z-1420-2016 | Class II | Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical proced | January 7, 2016 |
| Z-1451-2016 | Class II | Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical proce | January 7, 2016 |
| Z-1432-2016 | Class II | Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical | January 7, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260116 | CustoMED Viewer | June 3, 2026 |
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | January 5, 1998 |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | December 4, 1997 |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | November 25, 1996 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | October 4, 1996 |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | September 27, 1996 |
| K961442 | UNIVERSAL DRAINAGE TRAY | May 9, 1996 |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | October 2, 1995 |
| K950295 | WOUND CLOSURE/LACERATION TRAY | April 18, 1995 |
| K942177 | FOLEY CATHETERIZATION TRAY | September 8, 1994 |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | August 27, 1993 |
| K925017 | IV PREP KIT (NON-STERILE) | August 27, 1993 |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | July 14, 1993 |
| K925020 | TRACHEOSTOMY CARE KIT (STERILE) | July 7, 1993 |
| K925021 | TPN TRAY (STERILE) | June 7, 1993 |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | June 7, 1993 |
| K925015 | STERILE SUTURE REMOVAL KIT | June 7, 1993 |
| K925016 | PREP SHAVE KIT (NON-STERILE) | April 26, 1993 |
| K925022 | SURGICAL TRAY (STERILE) | April 26, 1993 |
| K904693 | CUSTOMED CARDIOVASCULAR PACK | January 2, 1991 |