Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 13, 2020
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gentell, Inc recalled Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydro… - a moderate-severity action.
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydro… was recalled by Gentell, Inc in May 13, 2020. Reason: During an FDA audit, it was discovered that the product was not properly registered with FDA.. Check the official notice for the remedy. Verify recall #Z-1908-2020 with the FDA Devices before acting.
The recall
Gentell, Inc issued this moderate-severity FDA Devices recall-During an FDA audit, it was discovered that the product was not properly registered with FDA..
- Moderate
- severity level
- 22K units
- affected scope
- Class II
- classification
- May 13, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1908-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1908-2020) was formally reported on May 13, 2020, with the manufacturer initiating the action on March 26, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Gentell, Inc is listed as the recalling firm, operating out of Bristol, PA. Federal records list the affected scope as 22,439.
The documented reason for this recall is: During an FDA audit, it was discovered that the product was not properly registered with FDA. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distributions and the country of South Africa.. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22,439
Related Recalls
6
0 from same agency
Product description
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
Reason for recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1908-2020 |
| Date reported | May 13, 2020 |
| Date initiated | March 26, 2020 |
| Recalling firm | Gentell, Inc |
| Firm location | Bristol, PA |
| Affected scope | 22,439 |
| Distribution | Worldwide distribution - US Nationwide distributions and the country of South Africa. |
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-1908-2020) 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? ▼
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions. Recalled by Gentell, Inc. Units affected: 22,439.
Why was this product recalled? ▼
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1908-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distributions and the country of South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1908-2020) 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.
Continue exploring
Keep tracking product safety across the federal recall archive.
Recall Checker
Search the full archive by product name, brand, or recall number across every agency.
Check a product →
FDA Devices recalls
Every recall issued by FDA Devices, newest first.
Browse the feed →
RecallRadar
Live feed of the latest recalls across the FDA, CPSC and NHTSA, filter by agency and severity.
View the live feed →
Rankings
The largest recalls by units affected and the most-recalled product categories.
See the rankings →
Browse by category
Find recalls by product type to spot recurring defect patterns.
All categories →
What to do next
A step-by-step guide to refunds, repairs, and returns after a recall.
Read the guide →
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 13, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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.