Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 27, 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 Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99
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 sto…
Synapse Biomedical Inc recalled NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # … - a low-severity action.
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # … was recalled by Synapse Biomedical Inc in July 27, 2022. Reason: Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to…. Check the official notice for the remedy. Verify recall #Z-1393-2022 with the FDA Devices before acting.
The recall
Synapse Biomedical Inc issued this low-severity FDA Devices recall-Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to….
- Low
- severity level
- 71 units
- affected scope
- Class III
- classification
- July 27, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1393-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1393-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on May 31, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Synapse Biomedical Inc is listed as the recalling firm, operating out of Oberlin, OH. Federal records list the affected scope as 71.
The documented reason for this recall is: 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 condit… Distribution data in the federal record shows the product reached: Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
71
Related Recalls
6
3 from same agency
Product description
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 Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
Reason for recall
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1393-2022 |
| Date reported | July 27, 2022 |
| Date initiated | May 31, 2022 |
| Recalling firm | Synapse Biomedical Inc |
| Firm location | Oberlin, OH |
| Affected scope | 71 |
| Distribution | Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1393-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006. Recalled by Synapse Biomedical Inc. Units affected: 71.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Low. Recall number: Z-1393-2022.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1393-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 27, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.