Custom Medical Specialties, Inc.: FDA recalls

FDA enforcement reports name Custom Medical Specialties, Inc. as the recalling firm in 5 events. The events have 21 product records. The recalls started from 2011 to 2016.

See the 5 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

5 events, newest first.

FDA enforcement events of Custom Medical Specialties, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
20 Sep 2016	CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.	Device	Class II	1	Ongoing
12 Jul 2013	5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover	Device	Class II	1	Terminated
23 Jul 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 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.	Drug	Class II	3	Terminated
30 Sep 2011	CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep	Device	Class II	4	Terminated
30 Sep 2011	CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep	Device	Class I	12	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Custom Medical Specialties, Inc.: events for each product type
Type		Events
Device		4
Drug		1

Custom Medical Specialties, Inc.: events in each class
Class		Events
Class II		4
Class I		1

Share of the events of the firm in Class I: 20%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Custom Medical Specialties, Inc., by the year that the recall started. The largest year is 2011, with 2 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Custom Medical Specialties, Inc.: FDA recalls. https://recallregister.com/firm/custom-medical-specialties-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: NC

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Custom Medical Specialties, Inc. have?: Class II: 4 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Custom Medical Specialties, Inc. have?: Device: 4 events. Drug: 1 event.
What is the newest FDA recall of Custom Medical Specialties, Inc.?: FDA event 76276, which the firm started on 20 Sep 2016. The first product in the record is: CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
How many FDA recalls of Custom Medical Specialties, Inc. have the status Ongoing?: 1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.