thejoe Customed, Inc

Customed, Inc: 682 FDA recall reports

Every medical device recall the FDA has published for Customed, Inc. The fault, and how the agency graded it.

682Reports

412Class I

0Ongoing

2016-04-20Most recent

412 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class I	412
Class II	270

By year reported

Year	Reports
2014	412
2015	170
2016	100

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and

Z-1465-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 96

Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and p

Z-1454-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 136

Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patien

Z-1426-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 70

Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perfo

Z-1411-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 2800

Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures

Z-1423-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 40

Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures an

Z-1480-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 800

Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and p

Z-1492-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 8

Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and

Z-1462-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 85

Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and p

Z-1490-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 238

Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and pati

Z-1429-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 550

Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and p

Z-1403-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 132

Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medi

Z-1475-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 1148

Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical proced

Z-1479-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 144

Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK

Z-1401-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Where it went: Distributed only in Puerto Rico.
How much: 60

Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and

Z-1455-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 47

Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patien

Z-1466-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 55

Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical p

Z-1456-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 24

Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient

Z-1452-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 18

Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgica

Z-1400-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 4400

Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and

Z-1488-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 580

Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and

Z-1438-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 168

Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and

Z-1451-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 76

Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and

Z-1443-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 150

Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and pat

Z-1410-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 80

Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and pat

Z-1424-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 200

Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to p

Z-1413-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 380

Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patien

Z-1405-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 4550

Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and p

Z-1397-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: 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.
Where it went: Distributed only in Puerto Rico.
How much: 540

Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and pa

Z-1428-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 24

Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and

Z-1476-2016 · Class II · reported 2016-04-20 · Terminated

Why it was recalled: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Product: Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Where it went: Distributed only in Puerto Rico.
How much: 620

Showing the 30 most recent of 682. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All device recalls