Recall Weekly
Serious riskFDA DeviceClass I

Erbe USA flexible cryoprobe recalled for possible rupture during use

Erbe USA Inc. is recalling certain Flexible Cryoprobe surgical devices (model OD 1.7mm, L1.15mm, REF: 20402-410) because the probes may rupture or burst when activated during surgery. This defect could cause injury to patients or surgical staff. No injuries have been reported so far.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have any affected cryoprobes by matching the lot numbers to your inventory.
  2. Stop using any probes from the affected lots immediately.
  3. Contact Erbe USA Inc. for instructions on returning or replacing the devices.
  4. Review your surgical schedules and notify patients if their procedures may be affected.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
5154 units
Illnesses reported
None reported
Manufactured in
2225 Northwest Pkwy SE, Marietta, GA, United States
Classification
Class I
Recall number
Z-1567-2026

In the FDA's words

Description
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use Probes may rupture/burst during activation UDI: 04050147021822/ Lots: WO459860 WO462187 WO462322 WO462390 WO462391 WO462392 WO462393 WO462396 WO462677 WO462678 WO463323 WO463324 WO463325 WO463326 WO463386 WO463387 WO464280 WO464281 WO464282 WO464283 WO464284 WO465059 WO465060 WO465061 WO465062 WO467876 WO467877 WO467878 WO467879 WO468225 WO468226 WO468227 WO468642 WO468643 WO468644 WO468645 WO468647 WO468671 WO468672 WO468673 WO468674 WO469361 WO469362 WO469363 W2459858 W2459958 W2462283 W2463593 W2465596 W2465623 W2465693 W2465768 W2468859 W2470050 W2470051 W2470052 W4465597 Distribution: US Nationwide distribution, including Puerto Rico. Affected quantity: 5154 units
Hazard
Probes may rupture/burst during activation

3 products in this recall

Erbe flexible cryoprobes recalled for probe rupture risk

Erbe is recalling three models of flexible cryoprobes used in surgery because the probes may rupture or burst during activation. The recall covers about 40,900 units sold nationwide, including Puerto Rico. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Erbe

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