Swan-Ganz Catheters Models 131F7 Through AIQSGF8 Recalled Nationwide
Becton, Dickinson and Company is recalling multiple models of Swan-Ganz Catheters due to potential leaking or breaking of the proximal injectate lumen hub that could lead to infection, medication loss, or blood loss.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device with potential for serious harm including infection, medication loss, and blood loss in hospitalized patients. Although no reported illnesses are stated in the source, the inherent risk of infection and blood loss in patients using central venous catheters, combined with the Class II classification, meets the criterion for Severe (score 4).
Plain-English summary
Becton, Dickinson and Company is recalling Swan-Ganz Catheters across multiple models (131F7, 131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6, 096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75, 831F75P, TS105F5, 774F75, 777F8, and AIQSGF8). The catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing process and material changes.
A total of 589,223 affected catheters have been distributed nationwide across the United States and internationally to countries including Japan, Brazil, Colombia, Australia, Canada, and numerous others. Specific lot numbers and expiration dates are documented for each model variant.
The potential for leaking or breaking of the catheter hub could lead to infection, medication loss, and blood loss. Patients and healthcare providers should inspect affected catheters and contact their healthcare provider if they have any concerns regarding catheters already in use.
The recalled product
- Product
- Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
- Manufacturer
- Becton, Dickinson and Company
- Affected units
- 589,223
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/UDI-DI/Lot(Expiration): 131F7P/00690103000412/65902900(8/1/2026)
- 65902901(8/3/2026)
- 65910728(8/2/2026)
- 65910729(7/29/2026)
- 65910730(7/27/2026)
- 65910731(7/25/2026)
- 65910732(7/26/2026)
- 65910735(7/30/2026)
- 65910736(8/24/2026)
- 65910737(7/31/2026)
- 65916927(8/3/2026)
- 65916928(8/6/2026)
- 65916929(8/7/2026)
- 65916930(8/8/2026)
- 65916931(8/9/2026)
- 65916932(8/22/2026)
- 65916933(8/23/2026)
- 65944791(8/20/2026)
- 65944792(8/21/2026)
- 65955857(9/9/2026)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Becton, Dickinson and Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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