Lower risk Medical device recall · FDA · Published January 17, 2022

Lacrimedics Collagen Plugs Recall: Sterile Pouch Seal Risk

Lacrimedics recalls specific collagen plug models due to potential pouch seal issues that could compromise sterility. Affected products include CP3, CP4, and CP5 dry eye treatments with certain lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0709-2022Medical device Lacrimedics ›

Lower-risk recall

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

Take action

Contact the company

Recalling firmLacrimedics Inc2620 Williamson Pl Ste 113 · Dupont, WA 98327-9518

✎ GovInfoNow plain-language explainer

Lacrimedics is recalling specific collagen plug models (CP3, CP4, CP5) for dry eye treatment. The recall is due to a potential issue with the sterile pouch seal that could compromise sterility, meaning the products might not be safe for use. Read more at govinfonow.com/recall/61257-lacrimedics-collagen-plugs-recall-sterile-pouch-seal-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61257-lacrimedics-collagen-plugs-recall-sterile-pouch-seal-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0709-2022

Cite this page

“Lacrimedics Collagen Plugs Recall: Sterile Pouch Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61257-lacrimedics-collagen-plugs-recall-sterile-pouch-seal-risk. Based on FDA recall #Z-0709-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0709-2022%22&limit=1).

The FDA announced on Jan. 17, 2022, that Lacrimedics Inc. is recalling Collagen Plugs due to potential sterility compromise from seal defects. Owners should contact the company for a refund, according to the FDA.

How to tell if you have it

Brand: Lacrimedics
Product: Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Lot codes: CP3 010421-3358, CP3 031419-3125, CP3 032921-3429, CP3 042020-3284, CP3 052219-3149, CP3 061521-3482, CP3 071720-3322, CP3 080218-3045, CP3 091218-3057, CP3 122118-3093, CP4 010621-3377, CP4 022619-3094, CP4 041620-3285, CP4 041719-3126, CP4 072020-3323, CP4 092518-3058, CP5 011221-3359, CP5 033121-3430, CP5 042219-3127, CP5 042220-3286, CP5 072320-3324, CP5 082318-3010, CP5 111418-3059, HP7 103018-3062
Units affected: 4780

The hazard

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility, according to the FDA.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12) and Medline Convenience Kits Recall: Potential Sterility Breach in Packaging (2026-06-12). Additional related actions include the Medline PowerGlide Dressing Kits Recall: Open Seal Risk on 2025-12-24.

How to tell if you have this one

Check the product label for the model number (CP3, CP4, or CP5) and the lot number listed in the recall notice. The products are for dry eye treatment and require a prescription.

Brand
Lacrimedics
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK

Recall number	Product, codes & lots	Quantity
Z-0708-2022	OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment; HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062	5767 units
Z-0709-2022	Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment; CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062	4780 units

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number (CP3, CP4, or CP5) and lot number on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 51 days after the firm started it.

Jan 17, 2022Firm started the recall
Mar 1, 2022FDA classified it Class II
Mar 9, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61257-lacrimedics-collagen-plugs-recall-sterile-pouch-seal-risk">Lacrimedics Collagen Plugs Recall: Sterile Pouch Seal Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0709-2022 (January 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0709-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.