CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Ferndale Laboratories recalled by Custom Interventional Pain
Custom Interventional Pain Management is recalling Ferndale Laboratories, distributed nationwide in the US. The recall was initiated on 15 Jan 2026 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-0067-2027
- FDA event ID
- 99699
- Recalling firm
- Custom Interventional Pain Management, San Antonio, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jan 2026
- FDA classified
- 1 Oct 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 15 Jan 2026 | Recall initiated by company | |
| 1 Oct 2026 | Classified by FDA | +259 days |
| 7 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM) Software Version: n/a Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures. Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of regional anesthesia. Component: surgical kits
Where it was distributed
U.S. Nationwide distribution in the state of TX.
Questions about this recall
Why was it recalled?
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Which lots are affected?
Lot Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray; Item #110026; Received Lot# 27022; Affected Lot #1225271; Expiration Date: 01/31/2028; DHR or Batch Record #64591; UDI: *+B87517LIDO/$$20131281225271T* UDI- DI #: B87517LID0 with Lidocaine
Where was it sold?
U.S. Nationwide distribution in the state of TX.
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 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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