Allen Medical Systems, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2013–2017 · MA

Allen Medical Systems, Inc. has 3 FDA enforcement events on this register (3 product records) between 2013 and 2017: 3 device; the busiest year was 2013 with 1.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
3 Jan 2017	Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.	Device	Class II	1	Terminated
23 Nov 2016	Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.	Device	Class II	1	Terminated
28 Feb 2013	Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Allen Medical Systems, Inc. by year initiated.

Questions and answers

How many FDA recalls has Allen Medical Systems, Inc. had?

3 enforcement events (3 product records) on this register, 2013–2017: 3 device.

Are any Allen Medical Systems, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Allen Medical Systems, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.