🔍 RecallPedia

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;

Class I - Dangerous
🏥 Medical Devices Recalled: May 18, 2023 MEDLINE INDUSTRIES, LP - Northfield Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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;

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2191-2023

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