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U.S. Department of Health and Human Services

Class 2 Device Recall BodyJet

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 Class 2 Device Recall BodyJetsee related information
Date Initiated by FirmOctober 18, 2024
Date PostedFebruary 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1251-2025
Recall Event ID 96137
510(K)NumberK082025 
Product Classification System, suction, lipoplasty for removal - Product Code QPB
Producthuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Code Information Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.
Recalling Firm/
Manufacturer		 HUMAN MED AG
Wilhelm-Hennemann-Str. 9
Schwerin Germany
Manufacturer Reason
for Recall		The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued a Field Safety Notice to Distributors dated 10/18/2025 via email explaining the reason for the Field Safety Notice, the potential hazard, and informing the consignee to discontinue delivering the affected products to customers and users and to dispose of the product if still in their warehouse. A Field Safety Notice was enclosed to be issued to the consignee's users and customers who received the affected product from the Distributor. The User and Customer letter dated 10/17/2024 was similar to the Distributor letter except provided instructions to check the spray pattern as instructed in the user manuals prior to using the cannula. If the pattern was not in a flat, fan-shaped pattern, they are not to use the cannula and it should be sorted out and disposed of properly. A confirmation form was enclosed to confirm the cannula has been correctly disposed of and the form was to be sent to the distributor or to the email address provided.
Quantity in Commerce775 devices
DistributionUS Nationwide distribution in the state of FL.
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 = QPB
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