FDA Class II Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name:… by B Braun Medical Inc — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is B Braun Medical Inc and the affected product is described in FDA's record as: Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No. FDA's stated reason for the recall is: B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.. The recall is tracked under FDA recall number Z-2267-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No -- and the recall number Z-2267-2026. If it matches, stop using or distributing it and contact B Braun Medical Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

B BRAUN MEDICAL INC’s FDA history

Argus HQ has recorded 22 total FDA actions tied to B BRAUN MEDICAL INC: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No) and recall number Z-2267-2026, then follow B Braun Medical Inc's recall instructions.

Has B Braun Medical Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 22 total FDA actions tied to B Braun Medical Inc, including 22 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2267-2026.

Related enforcement actions