Class II FDA device recall · Z-2191-2023

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) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number DYNJ44322I; e) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D; f) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F; g) IR ARM PACK, Model Number DYNJ50712C; h) HYBRID PACK, Model Number DYNJ56907D; i) TUNNEL PACK, Model Number DYNJ58127B; j) CRANIOTOMY PACK, Model Number DYNJ61749A; k) CARPAL TUNNEL KIT, Model Number DYNJ63149A; l) ANGIOGRAPHY PACK, Model Number DYNJ65963A; m) ARTHROSCOPY PACK, Model Number DYNJ66402; n) ARTHROSCOPY PACK, Model Number DYNJ66402A; o) ARTHROSCOPY PACK, Model Number DYNJ66402C; p) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404; q) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404A; r) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404B; s) ARTHROSCOPY PACK, Model Number DYNJ68997; t) MURRIETA PACK, Model Number DYNJ69312; u) MURRIETA PACK, Model Number DYNJ69312A; v) SHOULDER ARTHROSCOPY PACK, Model Number DYNJ82077; w) SCO ARTHROSCOPY, Model Number DYNJ906551A; x) US JOINT KIT, Model Number DYNJRA1944; y) HIP FRACTURE NERVE BLOCK, Model Number DYNJRA2085; z) ENS STERILE POUR IMPLANT-LF, Model Number OST011E; aa) ARTHROGRAM TRAY, Model Number PAIN1524C; bb) SHOULDER PACK-LF, Model Number PHS41748D; cc) LOWER EXTREMITY BLOCK PACK-RX, Model Number SPEC0204D; dd) UPPER EXTREMITY BLOCK PACK-RX, Model Number SPEC0205F;

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 CDS982889I, UDI/DI (EA) 10889942208067, UDI/DI (CS) 40889942208068;  b) Model Number DYNDH1722, UDI/DI (EA) 10195327132163, UDI/DI (CS) 40195327132164;  c) Model Number DYNJ0604434X, UDI/DI (EA) 10889942763801, UDI/DI (CS) 40889942763802;  d) Model Number DYNJ44322I, UDI/DI (EA) 10193489530612, UDI/DI (CS) 40193489530613;  e) Model Number DYNJ44348D, UDI/DI (EA) 10889942646722, UDI/DI (CS) 40889942646723;  f) Model Number DYNJ44348F, UDI/DI (EA) 10193489530650, UDI/DI (CS) 40193489530651;  g) Model Number DYNJ50712C, UDI/DI (EA) 10193489870169, UDI/DI (CS) 40193489870160;  h) Model Number DYNJ56907D, UDI/DI (EA) 10193489831566, UDI/DI (CS) 40193489831567;  i) Model Number DYNJ58127B, UDI/DI (EA) 10193489482799, UDI/DI (CS) 40193489482790;  j) Model Number DYNJ61749A, UDI/DI (EA) 10195327063016, UDI/DI (CS) 40195327063017;  k) Model Number DYNJ63149A, UDI/DI (EA) 10193489786477, UDI/DI (CS) 40193489786478;  l) Model Number DYNJ65963A, UDI/DI (EA) 10193489992052, UDI/DI (CS) 40193489992053;  m) Model Number DYNJ66402, UDI/DI (EA) 10193489352016, UDI/DI (CS) 40193489352017;  n) Model Number DYNJ66402A, UDI/DI (EA) 10193489840520, UDI/DI (CS) 40193489840521;  o) Model Number DYNJ66402C, UDI/DI (EA) 10193489938456, UDI/DI (CS) 40193489938457;  p) Model Number DYNJ66404, UDI/DI (EA) 10193489352078, UDI/DI (CS) 40193489352079;  q) Model Number DYNJ66404A, UDI/DI (EA) 10193489840537, UDI/DI (CS) 40193489840538;  r) Model Number DYNJ66404B, UDI/DI (EA) 10193489941166, UDI/DI (CS) 40193489941167;  s) Model Number DYNJ68997, UDI/DI (EA) 10193489874655, UDI/DI (CS) 40193489874656;  t) Model Number DYNJ69312, UDI/DI (EA) 10193489929461, UDI/DI (CS) 40193489929462;  u) Model Number DYNJ69312A, UDI/DI (EA) 10195327216771, UDI/DI (CS) 40195327216772;  v) Model Number DYNJ82077, UDI/DI (EA) 10195327166953, UDI/DI (CS) 40195327166954;  w) Model Number DYNJ906551A, UDI/DI (EA) 10195327124083, UDI/DI (CS) 40195327124084;  x) Model Number DYNJRA1944, UDI/DI (EA) 10195327133047, UDI/DI (CS) 40195327133048;  y) Model Number DYNJRA2085, UDI/DI (EA) 10195327286743, UDI/DI (CS) 40195327286744;  z) Model Number OST011E, UDI/DI (EA) 10888277589322, UDI/DI (CS) 40888277589323;  aa) Model Number PAIN1524C, UDI/DI (EA) 10195327271602, UDI/DI (CS) 40195327271603;  bb) Model Number PHS41748D, UDI/DI (EA) 10193489784794, UDI/DI (CS) 40193489784795;  cc) Model Number SPEC0204D, UDI/DI (EA) 10193489302981, UDI/DI (CS) 40193489302982;  dd) Model Number SPEC0205F, UDI/DI (EA) 10193489212884, UDI/DI (CS) 40193489212885

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-2191-2023
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-2191-2023 · Source: openFDA enforcement.