Z-1568-2025Class II

Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood...

Name: Z-1568-2025 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood...
Creator: Baxter Healthcare Corporation
Published: 2025-03-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2025-03-21 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH... on 2025-03-21. FDA classified it as Class II and gives the reason as "Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs". 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-1568-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-21
Posted: 2025-04-15
Recalling firm: Baxter Healthcare Corporation
Product: Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Product code: DXQ Blood Pressure Cuff
Reason for recall: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/21/2025 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate the impacted products (see Attachment A for details) at your facility that are unopened. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed Reply Form Instruction Sheet, even if you have no remaining inventory. 3. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for the return and exchange of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Director of Nursing, and any other departments within your institution who unpack the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) and you have an affected product please do not distribute. Contact Baxter Technical Support for additional instructions. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, please contact Baxter Technical Support between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday at 800-535-6663. Press option 2, then select option 1 or 2 for language preference, then press option 2.
Quantity in commerce: 76407 units
Distribution: Worldwide distribution.
Product codes and lots: 1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Product Code/Part # 47-23-189, UDI/DI 00732094002362; Product Code/Part # 5082-01, UDI/DI 00732094113723; Product Code/Part # 5082-01H, UDI/DI 00732094113693; Product Code/Part # 5082-02, UDI/DI 00732094113679; Product Code/Part # 5082-03, UDI/DI 00732094113648; Product Code/Part # 5082-07, UDI/DI 00732094113631; Product Code/Part # 5082-08, UDI/DI 00732094113600; Product Code/Part # 5082-11, UDI/DI 00732094113327; Product Code/Part # 5082-16, UDI/DI 00732094113105; Product Code/Part # 5082-21, UDI/DI 00732094112344; Product Code/Part # 5082-22, UDI/DI 00732094112290; Product Code/Part # 5082-22H, UDI/DI 00732094112276; Product Code/Part # 5082-23, UDI/DI 00732094112245; Product Code/Part # 5082-23H, UDI/DI 00732094112221; Product Code/Part # 5082-24, UDI/DI 00732094112207; Product Code/Part # 5082-25, UDI/DI 00732094111996; Product Code/Part # 5082-26, UDI/DI 00732094111897; Product Code/Part # 5082-42, UDI/DI 00732094111873; Product Code/Part # 5082-43, UDI/DI 00732094111842; Product Code/Part # 5082-44, UDI/DI 00732094111811; Product Code/Part # 5082-45, UDI/DI 00732094111798; Product Code/Part # 5082-77, UDI/DI 00732094111644; Product Code/Part # 4500-02, UDI/DI 00732094004199; Product Code/Part # 4500-03, UDI/DI 00732094004182; Product Code/Part # 45-15-389, UDI/DI 00732094004472; Product Code/Part # 45-22-189, UDI/DI 00732094004397; Product Code/Part # 45-23-189, UDI/DI 00732094004380; Product Code/Part # 5082-78, UDI/DI 00732094111613; Product Code/Part # 5200-01, UDI/DI 00732094108583; Product Code/Part # 5200-02, UDI/DI 00732094108569; 2) Product Code/Part Number 410519, UDI/DI 00732094208610; Product Code/Part Number 5090-41, UDI/DI 00732094110494; Lot Number 24-314 & lower Product Code/Part Number 5098-20, UDI/DI 00732094109955;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1563-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1564-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1565-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1566-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1567-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15
Z-1568-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-15

Product code DXQ

K070060Class IIWelch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)Welch Allyn, Inc. / cleared 2007-12-18

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)