CLASS II ONGOING Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Opaque Herrick Lacrimal Plugs, HP3, HP5, HP7, Sterile, EO recalled
Lacrimedics is recalling Opaque Herrick Lacrimal Plugs, HP3, HP5, HP7, Sterile, EO, distributed nationwide in the US. The recall was initiated on 17 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0708-2022
- FDA event ID
- 89463
- Recalling firm
- Lacrimedics, Dupont, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jan 2022
- FDA classified
- 1 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Jan 2022 | Recall initiated by company | |
| 1 Mar 2022 | Classified by FDA | +43 days |
| 9 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Where it was distributed
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
Questions about this recall
Is Opaque Herrick Lacrimal Plugs, HP3, HP5, HP7, Sterile, EO recalled?
Yes. Lacrimedics recalled Opaque Herrick Lacrimal Plugs, HP3, HP5, HP7, Sterile, EO on 17 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0708-2022.
Why was it recalled?
The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lacrimedics
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Collagen Plugs, CP3, CP4, CP5, Sterile, EO recalled by Lacrimedics | Lacrimedics | Sterility | Nationwide |
| Device | CLASS III | VisiPlugST for the Lacrimal Efficiency Test recalled by Lacrimedics | Lacrimedics | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |