Class II U.S. Food and Drug Administration

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light recall: There is a potential for vaginal speculums to contain a burr on the proximal

Recall published 2 months ago

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

The hazard: Laceration or amputation hazard

This recall is about a cutting injury: a blade, edge or part that can reach the user when it should not.

What the notice says: There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

Why it matters: A blade, edge or moving part can cut the user, or a part can break and come apart in the hand. With powered tools, the same defect that causes a cut can cause a much worse injury.

Symptoms and when to call a doctor

Control bleeding with firm, direct pressure using a clean cloth and raise the limb if you can. Go to an emergency department for a wound that will not stop bleeding, that gapes open, that is deep or dirty, that involves a hand, face or joint, or where feeling or movement has changed. If a body part has been severed, call 911, wrap the part in clean damp gauze, seal it in a bag and keep the bag on ice — never directly on ice.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2933-2026
Published
August 19, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
OBP Medical Corporation
Product type
Medical devices
Units affected
8,224 boxes (148,032 units)
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: (01)20888937027451/ Lots: 24J1202Z, 25D2302Z, 25A0202Z, 25E1502Z, 25B2802Z, 25L0802Z
UPC codes
20888937027451

Products covered by this recall

OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 20888937027451

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24J1202Z
  • 25D2302Z
  • 25A0202Z
  • 25E1502Z
  • 25B2802Z
  • 25L0802Z — 8
  • 224 boxe

Model or item number

On the rating label, the box or the instruction sheet.

  • C020130-1 — UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Laceration

OBP Medical Corporation — This recall is about a cutting injury: a blade, edge or part that can reach the user when it should not.

  1. Stop using the product and unplug it, or take the battery out if it is cordless.
  2. Photograph any damage or breakage before you send the item back, because the company will often ask for it.
  3. Follow the remedy on this page and keep the receipt or order confirmation if you have one.
  4. Do not try to grind off, tape over or otherwise work around a sharp part — you cannot restore the guard the design is missing.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

Company contact: OBP Medical Corporation — 360 Merrimack St Ste 9, Lawrence, MA, 01843-1764

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was OBP Medical Corporation medical devices recalled?

There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider. There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 20888937027451; lot code 24J1202Z, 25D2302Z, 25A0202Z; model number C020130-1 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and unplug it, or take the battery out if it is cordless.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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