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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026