Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported January 9, 2013
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers…
Fisher & Paykel Healthcare, Ltd. recalled Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8… - a critical-severity action.
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8… was recalled by Fisher & Paykel Healthcare, Ltd. in January 9, 2013. Reason: FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorp…. Check the official notice for the remedy. Verify recall #Z-0621-2013 with the FDA Devices before acting.
The recall
Fisher & Paykel Healthcare, Ltd. issued this critical-severity FDA Devices recall-FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorp….
- Critical
- severity level
- 200 units
- affected scope
- Class I
- classification
- January 9, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0621-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0621-2013) was formally reported on January 9, 2013, with the manufacturer initiating the action on November 19, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Fisher & Paykel Healthcare, Ltd. is listed as the recalling firm, operating out of North Shore City, N/A. Federal records list the affected scope as 200 units total, 26 units US.
The documented reason for this recall is: FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including IL, IN, AR and GA.. 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
200 units total, 26 units US
Related Recalls
6
3 from same agency
Product description
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Reason for recall
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0621-2013 |
| Date reported | January 9, 2013 |
| Date initiated | November 19, 2012 |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Firm location | North Shore City, N/A |
| Affected scope | 200 units total, 26 units US |
| Distribution | Worldwide Distribution - USA including IL, IN, AR and GA. |
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-0621-2013) 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? ▼
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.. Recalled by Fisher & Paykel Healthcare, Ltd.. Units affected: 200 units total, 26 units US.
Why was this product recalled? ▼
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 9, 2013. Severity: Critical. Recall number: Z-0621-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including IL, IN, AR and GA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0621-2013) 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 January 9, 2013. 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.