Codman & Shurtleff Inc: FDA recalls

FDA enforcement reports name Codman & Shurtleff Inc as the recalling firm in 11 events. The events have 59 product records. The recalls started from 2013 to 2019. All the events are device recalls.

See the 11 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

11 events, newest first.

FDA enforcement events of Codman & Shurtleff Inc
Initiated	Product (first record)	Type	Class	Records	Status
16 May 2019	GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).	Device	Class II	1	Terminated
10 Nov 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.	Device	Class II	2	Terminated
5 Mar 2015	CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5” Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and…	Device	Class II	1	Terminated
15 Sep 2014	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt…	Device	Class II	3	Terminated
3 Jul 2014	Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.	Device	Class II	8	Terminated
13 Dec 2013	CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve…	Device	Class II	1	Terminated
11 Oct 2013	TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical…	Device	Class I	2	Terminated
13 Aug 2013	MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the…	Device	Class I	8	Terminated
7 Jun 2013	MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.	Device	Class I	2	Terminated
16 May 2013	Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of…	Device	Class II	7	Terminated
11 Jan 2013	NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	Device	Class II	24	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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Type and class

Codman & Shurtleff Inc: events for each product type
Type		Events
Device		11

Codman & Shurtleff Inc: events in each class
Class		Events
Class II		8
Class I		3

Share of the events of the firm in Class I: 27%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

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 Codman & Shurtleff Inc, by the year that the recall started. The largest year is 2013, with 6 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. Codman & Shurtleff Inc: FDA recalls. https://recallregister.com/firm/codman-shurtleff-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: MA, CA

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 Codman & Shurtleff Inc have?: Class II: 8 events. Class I: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Codman & Shurtleff Inc?: FDA event 83502, which the firm started on 16 May 2019. The first product in the record is: GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
How many FDA recalls of Codman & Shurtleff Inc have the status Ongoing?: No 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.