XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to t…

Recall #: Z-0598-2020
Affected scope: 145,711 Glaucoma Treatment Systems
Initiated: October 30, 2019

Compiled from official public sources by the publisher. · Updated September 2026

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Allergan PLC recalled XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model… - a moderate-severity action.

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model… was recalled by Allergan PLC in December 11, 2019. Reason: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the…. Check the official notice for the remedy. Verify recall #Z-0598-2020 with the FDA Devices before acting.

The recall

Allergan PLC issued this moderate-severity FDA Devices recall-Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the….

Moderate
severity level: Class II
classification: December 11, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0598-2020 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

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 moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

Reason for recall

Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0598-2020
Date reported	December 11, 2019
Date initiated	October 30, 2019
Recalling firm	Allergan PLC
Firm location	Irvine, CA
Affected scope	145,711 Glaucoma Treatment Systems
Distribution	Worldwide distribution. US nationwide, countries of AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, KR, LT, MT, MU, MX, MY, NA, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI,SK, SM,TH,TR, TW, VE, a…

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-0598-2020) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.. Recalled by Allergan PLC. Units affected: 145,711 Glaucoma Treatment Systems.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 11, 2019. Severity: Moderate. Recall number: Z-0598-2020.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution. US nationwide, countries of AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, KR, LT, MT, MU, MX, MY, NA, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI,SK, SM,TH,TR, TW, VE, and ZA..

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.

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 (Moderate), closest by report date among other firms and states.

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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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This recall: FDA Devices, reported December 11, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026