FDA Drug recall · Reported December 30, 2015
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Oasis Medical, Inc. recalled HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private La… - a low-severity action.
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private La… was recalled by Oasis Medical, Inc. in December 30, 2015. Reason: Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification …. Check the official notice for the remedy. Verify recall #D-0522-2016 with the FDA Drug before acting.
The recall
Oasis Medical, Inc. issued this low-severity FDA Drug recall-Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification ….
- Low
- severity level
- 15K units
- affected scope
- Class III
- classification
- December 30, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0522-2016 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 - 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
Reason for recall
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0522-2016 |
| Date reported | December 30, 2015 |
| Date initiated | October 19, 2015 |
| Recalling firm | Oasis Medical, Inc. |
| Firm location | Glendora, CA |
| Affected scope | 15,301 units |
| Distribution | Nationwide and Saudi Arabia, Israel, Chile, Norway, Ecuador, Greece, Switzerland, Canada, England, Columbia, Poland, South Africa, Germany, Pakistan, El Salvador, Dubai, Belgium |
Profile values are sourced directly from the official FDA Drug 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 (D-0522-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug 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 (Low), 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