FDA Device recall Z-2694-2026
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-…
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-… by Boston Scientific Neuromodulation, citing intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2694-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-22 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU
Reason
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Identifiers
| code_info | REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998,…REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751/04-Mar-2027 to 21-Jul-2027; RLV0035-EU/852454006448/36267790, 36909569, 38889437/04-Mar-2027 to 26-Jun-2027; RLV0045/852454006301/35218150, 35218151, 35218152, 35218153, 35219469, 35219470, 35229010, 35229011, 35229012, 35256597, 35318740, 35318741, 35318742, 35329853, 35329854, 35338734, 35360990, 35360991, 35360992, 35406849, 35406850, 35406851, 35406852, 35406853, 35406854, 35498172, 35508065, 35508066, 35523483, 35523484, 35525666, 35535444, 35535445, 35535446, 35535664, 35535665, 35536282, 35538112, 35538113, 35538114, 35538115, 35717797, 35717798, 35717861, 35729587, 35729588, 35729589, 35738091, 35738092, 35738093, 35755411, 35755412, 35755413, 35788378, 35788379, 35788400, 35789578, 35789579, 35789840, 35822293, 35822294, 35822295, 35831721, 35831722, 35831723, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2694-2026%22
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