RecallRadar

FDA Device recall Z-2539-2026

Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068

On 2026-07-08 the FDA classified a Class II recall of Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068 by Medline Industries, citing the kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to q….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2539-2026
ClassificationClass II
Statusongoing
Initiated2026-05-21
Published2026-07-08
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I

Reason

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Identifiers

code_info
1) DYNDH1068, UDI-DI: 10889942172122(each), 40889942172123(case), Lot Number: 2025101090; 2) PHS234706I, UDI-DI: 101984…1) DYNDH1068, UDI-DI: 10889942172122(each), 40889942172123(case), Lot Number: 2025101090; 2) PHS234706I, UDI-DI: 10198459330278(each), 40198459330279(case), Lot Number: 25JLB029

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2539-2026%22

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