Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1393-2022 — NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile

U.S. FDA — Device Enforcement · United States · 2022-05-31 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1393-2022
Date of alert
2022-05-31
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Synapse Biomedical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00852184003007
Reported risk: Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.