Customed, Inc

FDA recalling firm · 4 enforcement events · 682 product records · 2014–2016 · PR

Customed, Inc has 4 FDA enforcement events on this register (682 product records) between 2014 and 2016: 4 device; the busiest year was 2014 with 2.

50% of its events are Class I; the most common class is Class I (2). 0 events are listed as ongoing; the recalling firm's address is in PR.

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
7 Jan 2016	Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	Device	Class II	100	Terminated
10 Jul 2015	ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	Device	Class II	170	Terminated
8 Oct 2014	Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	Device	Class I	179	Terminated
20 May 2014	Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,&…	Device	Class I	233	Terminated

By type and class

Device4

Class I2

Class II2

Class I: 50% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Customed, Inc by year initiated.

Questions and answers

How many FDA recalls has Customed, Inc had?

4 enforcement events (682 product records) on this register, 2014–2016: 4 device.

Are any Customed, Inc recalls ongoing?

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

What class are Customed, Inc recalls?

2 Class I, 2 Class II. 50% 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.