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Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST ...

FDA Device Recall #Z-2170-2023 — Class II — May 18, 2023

Recall Summary

Recall Number Z-2170-2023
Classification Class II — Moderate risk
Date Initiated May 18, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 47185 units

Product Description

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;

Reason for Recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Distribution Pattern

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Lot / Code Information

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510; b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657; c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275; d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799; e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452; f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934; g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313; h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083; i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476; j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684; k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481; l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745; m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428; n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873; o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478; p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295; q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309; r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720; s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803; t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953; u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751; v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090; w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534; x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625; y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796; z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706; aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576; bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653; cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593; dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268; ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452; ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591; gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283; hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198; ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230; jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711; kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853; ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865;

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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