Z-2203-2023Class II

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

Name: Z-2203-2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY...
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: BREAST BIOPSY TRAY, Model Number SPEC0130C 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-2203-2023
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: BREAST BIOPSY TRAY, Model Number SPEC0130C
Product code: PXP Breast Biopsy / Localization Tray
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: 1240 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 - May 2023: Model Number SPEC0130C, UDI/DI (EA) 10193489196641, UDI/DI (CS) 20193489196648

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2203-2023
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 PXP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)