Z-2156-2023Class II

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

Name: Z-2156-2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-18
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-18 / Open, Classified / root cause: design

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number... on 2023-05-18. FDA classified it as Class II and gives the reason as "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2156-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-07-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1847; j) ANESTHESIA BLOCK PACK - TBR, Model Number DYNJRA1864; k) 18G CPNB 20G STYLETED CATHETER, Model Number DYNJRA1869; l) NERVE BLOCK TRAY, Model Number DYNJRA1878; m) BLOCK KIT, Model Number DYNJRA1893; n) NERVE BLOCK TRAY, Model Number DYNJRA1900; o) US TPI KIT, Model Number DYNJRA1945; p) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA1975; q) DR LEWIS US TRAY, Model Number DYNJRA1998; r) ULTRASOUND GUIDED NERVE BLOCK, Model Number DYNJRA2013; s) ULTRASOUND TRAY, Model Number DYNJRA2022; t) NERVE BLOCK INSERTION, Model Number DYNJRA2027; u) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028; v) PAIN PREP W/ PROBE COVER TRAY, Model Number DYNJRA2028A; w) PAIN TRAY, Model Number DYNJRA2041; x) SUPPORT TRAY, Model Number DYNJRA2044; y) SUPERFICIAL NERVE BLOCK, Model Number DYNJRA2086; z) NERVE BLOCK TRAY, Model Number DYNJRA2148; aa) TRAY 18G CPNB 20G STYLETED, Model Number DYNJRA9040; bb) ULTRASOUND BLOCK TRAY, Model Number DYNJRA9044; cc) PERIPHERAL NERVE CATHETER KT, Model Number PAIN1560; dd) PAIN PREP W/PROBE COVER TRAY, Model Number PAIN1762
Product code: OFT Spinal Epidural Anesthesia Kit
Reason for recall: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Root cause tag: design
FDA root cause: Device Design
Action: Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Quantity in commerce: 28568 units
Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Product codes and lots: all lots within expiry, distributed from Medline between December 2017 1 May 2023: a) Model Number DYNJ81722, UDI/DI (EA) 10195327136437, UDI/DI (CS)40195327136438; b) Model Number DYNJRA0827A, UDI/DI (EA) 10193489214468, UDI/DI (CS)40193489214469; c) Model Number DYNJRA0881, UDI/DI (EA) 10889942463930, UDI/DI (CS)40889942463931; d) Model Number DYNJRA0881A, UDI/DI (EA) 10195327262402, UDI/DI (CS)40195327262403; e) Model Number DYNJRA1603, UDI/DI (EA) 10193489299007, UDI/DI (CS)40193489299008; f) Model Number DYNJRA1739A, UDI/DI (EA) 10193489924954, UDI/DI (CS)40193489924955; g) Model Number DYNJRA1823, UDI/DI (EA) 10193489961881, UDI/DI (CS)40193489961882; h) Model Number DYNJRA1837, UDI/DI (EA) 10193489976717, UDI/DI (CS)40193489976718; i) Model Number DYNJRA1847, UDI/DI (EA) 10193489993660, UDI/DI (CS)40193489993661; j) Model Number DYNJRA1864, UDI/DI (EA) 10195327008789, UDI/DI (CS)40195327008780; k) Model Number DYNJRA1869, UDI/DI (EA) 10195327018818, UDI/DI (CS)40195327018819; l) Model Number DYNJRA1878, UDI/DI (EA) 10195327040376, UDI/DI (CS)40195327040377; m) Model Number DYNJRA1893, UDI/DI (EA) 10195327062828, UDI/DI (CS)40195327062829; n) Model Number DYNJRA1900, UDI/DI (EA) 10195327082253, UDI/DI (CS)40195327082254; o) Model Number DYNJRA1945, UDI/DI (EA) 10195327133054, UDI/DI (CS)40195327133055; p) Model Number DYNJRA1975, UDI/DI (EA) 10195327163242, UDI/DI (CS)40195327163243; q) Model Number DYNJRA1998, UDI/DI (EA) 10195327194291, UDI/DI (CS)40195327194292; r) Model Number DYNJRA2013, UDI/DI (EA) 10195327212049, UDI/DI (CS)40195327212040; s) Model Number DYNJRA2022, UDI/DI (EA) 10195327218164, UDI/DI (CS)40195327218165; t) Model Number DYNJRA2027, UDI/DI (EA) 10195327225223, UDI/DI (CS)40195327225224; u) Model Number DYNJRA2028, UDI/DI (EA) 10195327226299, UDI/DI (CS)40195327226290; v) Model Number DYNJRA2028A, UDI/DI (EA) 10195327352042, UDI/DI (CS)40195327352043; w) Model Number DYNJRA2041, UDI/DI (EA) 10195327243708, UDI/DI (CS)40195327243709; x) Model Number DYNJRA2044, UDI/DI (EA) 10195327247300, UDI/DI (CS)40195327247301; y) Model Number DYNJRA2086, UDI/DI (EA) 10195327286750, UDI/DI (CS)40195327286751; z) Model Number DYNJRA2148, UDI/DI (EA) 10195327363758, UDI/DI (CS)40195327363759; aa) Model Number DYNJRA9040, UDI/DI (EA) 10193489830514, UDI/DI (CS)40193489830515; bb) Model Number DYNJRA9044, UDI/DI (EA) 10193489888119, UDI/DI (CS)40193489888110; cc) Model Number PAIN1560, UDI/DI (EA) 10193489215380, UDI/DI (CS)40193489215381; dd) Model Number PAIN1762, UDI/DI (EA) 10193489962093, UDI/DI (CS)40193489962094;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2156-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2154-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2155-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2156-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2157-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2158-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2159-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2160-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2161-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2162-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2163-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2164-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2165-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2166-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2167-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2168-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2169-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2170-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2171-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2172-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2173-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2174-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2175-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2176-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2177-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2178-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2179-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2180-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2181-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2182-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2183-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2184-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2185-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2186-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2187-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2188-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2189-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2190-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2191-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2192-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2193-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2194-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2195-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2196-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2197-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2198-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2199-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2200-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2201-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2202-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2203-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2204-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2205-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code OFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)