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U.S. Department of Health and Human Services

Class 1 Device Recall Erbe Flexible Cryoprobe

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 Class 1 Device Recall Erbe Flexible Cryoprobesee related information
Date Initiated by FirmFebruary 12, 2026
Date PostedMarch 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1568-2026
Recall Event ID 98429
510(K)NumberK190651 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Code Information UDI: 04050147021846/ Lots: WO461840 WO461846 WO462097 W2462284 WO463327 WO463328 WO463388 W2463594 WO464285 WO464286 WO465063 WO465064 W4465351 W2465601 W2465689 W2465749 W2465769 WO467873 WO467874 WO467875 WO468648 WO468649 WO469364 W2459861 W2459862 W2459863
FEI Number 1000140388
Recalling Firm/
Manufacturer		 Erbe USA Inc
2225 Northwest Pkwy SE
Marietta GA 30067-8764
For Additional Information ContactErbe Field Action TEam
678-483-8499 Ext. 133
Manufacturer Reason
for Recall		Probes may rupture/burst during activation
FDA Determined
Cause 2		Process control
ActionOn February 12, 2026, ERBE USA issued a "Urgent: Medical Device Recall (Removal)" via E-Mail. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2.Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3.Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification. 4.Please contact Erbe at fieldaction.us@erbegroup.com or 678-483-8499, to obtain a Return Material Authorization number 5.Please complete the Response Form and return to Erbe 6.If a response is not received within 4 weeks of this letter, Erbe will provide a second and third reminder in 4-week increments. 7.If you have further distributed this product, identify your locations, and forward this notification to them. 8.Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.
Quantity in Commerce2408 units
DistributionUS Nationwide distribution, including Puerto Rico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEH
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