Class II FDA device recall · Z-2170-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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;

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2170-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-18

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2170-2023 · Source: openFDA enforcement.