Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported December 10, 2014
Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncon…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Customed, Inc recalled Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient ca… - a critical-severity action.
Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient ca… was recalled by Customed, Inc in December 10, 2014. Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged pac…. Check the official notice for the remedy. Verify recall #Z-0281-2015 with the FDA Devices before acting.
The recall
Customed, Inc issued this critical-severity FDA Devices recall-Customed products are being recalled because of compromised sterility, not limited to potentially damaged pac….
- Critical
- severity level
- 71 units
- affected scope
- Class I
- classification
- December 10, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0281-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0281-2015) was formally reported on December 10, 2014, with the manufacturer initiating the action on October 8, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Customed, Inc is listed as the recalling firm, operating out of Fajardo, PR. Federal records list the affected scope as 71.
The documented reason for this recall is: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condition… Distribution data in the federal record shows the product reached: US Distribution to Florida, New York and Puerto Rico... Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
71
Related Recalls
6
3 from same agency
Product description
Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recall
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0281-2015 |
| Date reported | December 10, 2014 |
| Date initiated | October 8, 2014 |
| Recalling firm | Customed, Inc |
| Firm location | Fajardo, PR |
| Affected scope | 71 |
| Distribution | US Distribution to Florida, New York and Puerto Rico.. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0281-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.. Recalled by Customed, Inc. Units affected: 71.
Why was this product recalled? ▼
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Critical. Recall number: Z-0281-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution to Florida, New York and Puerto Rico...
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0281-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 10, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.