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Custom Medical Specialties, Inc.

Complete recall history across all FDA and CPSC categories — 21 total recalls

Recall Summary

3 Drug Recalls 18 Device Recalls

Custom Medical Specialties, Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (3)

FDA drug safety enforcement actions by Custom Medical Specialties, Inc.

Date Product Reason Class
Jul 23, 2012 Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #:... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.... Class II
Jul 23, 2012 CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 m... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.... Class II
Jul 23, 2012 CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chlor... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.... Class II

Device Recalls (18)

FDA medical device enforcement actions by Custom Medical Specialties, Inc.

Date Product Reason Class
Sep 20, 2016 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... Sterility of syringe product could not be assured. Class II
Jul 12, 2013 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical S... No endotoxin (LAL) testing to proper level. Class II
Sep 30, 2011 CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution P... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiolo... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage:... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usag... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Pre... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-... The firm saw on the FDA web site a recall by the manufacturer due to no micro... Class II
Sep 30, 2011 CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution ... The firm saw on the FDA web site a recall by the manufacturer due to no micro... Class II
Sep 30, 2011 CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution Th... The firm saw on the FDA web site a recall by the manufacturer due to no micro... Class II
Sep 30, 2011 CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Produ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained... The firm saw on the FDA web site a recall by the manufacturer due to no micro... Class II
Sep 30, 2011 CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I
Sep 30, 2011 CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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