DistributorLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Custom Medical Specialties with 18 device recalls, 3 drug recalls and 1 510(k) clearance. The most recent is a device recall dated Sep 20, 2016: CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile,….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 20, 2016 | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, InClass II · Sterility of syringe product could not be assured. | Device recalls |
| Jul 12, 2013 | 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts tClass II · No endotoxin (LAL) testing to proper level. | Device recalls |
| Jul 23, 2012 | CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical SpecialtiesClass II · Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject | Drug recalls |
| Jul 23, 2012 | CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 Class II · Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject | Drug recalls |
| Jul 23, 2012 | Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 JClass II · Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject | Drug recalls |
| Sep 30, 2011 | CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skiClass I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Sep 30, 2011 | CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVClass I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Sep 30, 2011 | CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin pClass I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Sep 30, 2011 | CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin Class I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Sep 30, 2011 | CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used inClass I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Sep 30, 2011 | BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kClass I · The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial t | Device recalls |
| Jan 27, 1995 | CUSTOM MEDICAL SUSPENSION STRAPK944988 · JAY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
