FDA Device Recall Z-0034-2025: MEDLINE INDUSTRIES, LP Northfield

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2025.

Recall Res Number

Z-0034-2025

Recalling Firm / Manufacturer

MEDLINE INDUSTRIES, LP Northfield

FEI Number

1417592

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-30

Date Posted

2024-10-08

Date Terminated

N/A

Product Code

DXN

Event Number

95318

Product Quantity

7,428 units

Product Description MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Reason for Recall It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.

Action Details Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 08/30/2024 via email and USPS first class mail. The notice explained the problem, risk to user and requested that units demonstrating the failure be discarded. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Medline issued a follow up notification to distributors on 09/13/2024. The notification contained the same information as the initial letter, but also instructed distributors to notify customers if the product was further distributed.

Distribution Pattern Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.

Code Information / Serial Numbers GTIN 00193489012548 Lot Numbers: L230480008, L230780008, L231080008, L231280008, L240280008

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SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD Registration: 3043047278 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
ANRIWELL Registration: 3043513123 View Registration
MIDMARK CORP. Registration: 3043668257 View Registration
A and D Engineering, Inc. Registration: 3044174020 View Registration
SHENZHEN HANHAN TECHNOLOGY CO., LTD Registration: 3045076243 View Registration
NIHON SEIMITSU SOKKI CO., LTD. Registration: 8010061 View Registration
RUDOLF RIESTER GMBH Registration: 8010482 View Registration
MICROLIFE CORP. Registration: 8020605 View Registration
Merit Medical Singapore Pte. Ltd. Registration: 8020616 View Registration
AMG MEDICAL INC. Registration: 8022077 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
OMRON HEALTHCARE CO., LTD. Registration: 8030245 View Registration
LODE B.V. Registration: 8030476 View Registration
SCHILLER AG Registration: 8030978 View Registration
CITIZEN SYSTEMS JAPAN CO., LTD. Registration: 8031509 View Registration
K-JUMP HEALTH CO., LTD. Registration: 8043510 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
FUKUDA DENSHI CO., LTD. Registration: 9611031 View Registration
OMRON HEALTHCARE Co., Ltd. Matsusaka Factory Registration: 9611045 View Registration
SPACELABS HEALTHCARE LTD. Registration: 9611295 View Registration
Dongguan Mars Medical Products Co., Ltd. Registration: 9615583 View Registration
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG Registration: 9615817 View Registration
SELVAS Healthcare, Inc. Registration: 9616164 View Registration
Health & Life Corporation Registration: 9616390 View Registration
LIDCO LTD. Registration: 9617127 View Registration
IEM GMBH Registration: 9617476 View Registration
AVITA CORPORATION Registration: 9617543 View Registration
ICU MEDICAL DE MEXICO, S. de R.L. de C.V. Registration: 9617594 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
ONBO ELECTRONIC (SHENZHEN) CO. LTD. Registration: 9680225 View Registration
ROSSMAX INTERNATIONAL LTD. Registration: 9680548 View Registration
Nicolay GMBH Registration: 9681377 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration
ATCOR MEDICAL Pty Ltd Registration: 9710654 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0034-2025

Recall Parameters & Description

Related Establishments / Registrations

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