Lumbar Puncture Tray Devices Recalled for Manometer Leaking and Mating Issues
Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with a functional defect (manometer leaking and mating issues) that could compromise proper procedure performance. No illnesses or injuries are reported in the source, aligning with the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling SAFE-T PLUS Lumbar Puncture Tray Adult devices due to manometer failure involving leaking and mating issues. The manometer is responsible for measuring cerebrospinal fluid pressure during lumbar puncture procedures.
The recall affects 15,650 devices distributed nationwide across all U.S. states and Puerto Rico, as well as internationally in Costa Rica and Hong Kong. Affected devices are identified by catalog number 4306CSP and specific lot numbers listed in the FDA recall notice.
Healthcare providers and facilities should contact Bard Peripheral Vascular Inc. for information on replacing or returning affected devices.
The recalled product
- Product
- SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device
- Affected units
- 15,650
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 (1)
- Catalog Number: 4306CSP Lot Numbers/UDI (GTIN
Distribution
Part of a larger recall action
This product is one of 11 recalled by Bard Peripheral Vascular Inc 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 11 products in this recall →Related recalls
Same manufacturer · Bard Peripheral Vascular Inc
See all →- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDrainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
- ModerateVein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
- CriticalRotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12
Same hazard · leaking
See all →- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking
FDA (Devices) · 2025-05-07
Similar recalls
- ModerateSmiths Medical Recalls Mislabeled Portex Lumbar Puncture Trays
FDA (Devices) · 2020-05-06
- ModerateBard Intra-abdominal Pressure Monitoring Device Recalled for Potential Leaks
FDA (Devices) · 2020-02-19
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13
- ModerateBusse Lumbar Puncture Tray Recalled for Foreign Matter
FDA (Devices) · 2018-02-14
- LowCirculatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
FDA (Devices) · 2016-10-19
- CriticalManual resuscitators recalled because blocked manometer port may disable pressure gauge
FDA (Devices) · 2025-08-20