Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 24, 2018
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pad…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DeRoyal Industries Inc recalled DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syr… - a moderate-severity action.
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syr… was recalled by DeRoyal Industries Inc in January 24, 2018. Reason: DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Pist…. Check the official notice for the remedy. Verify recall #Z-0334-2018 with the FDA Devices before acting.
The recall
DeRoyal Industries Inc issued this moderate-severity FDA Devices recall-DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Pist….
- Moderate
- severity level
- Class II
- classification
- January 24, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0334-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0334-2018) was formally reported on January 24, 2018, with the manufacturer initiating the action on December 19, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. DeRoyal Industries Inc is listed as the recalling firm, operating out of Powell, TN. Federal records list the affected scope as 226 kits.
The documented reason for this recall is: DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recal… Distribution data in the federal record shows the product reached: Distributed to states of: CA and MO.. 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 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
226 kits
Related Recalls
6
3 from same agency
Product description
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
Reason for recall
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0334-2018 |
| Date reported | January 24, 2018 |
| Date initiated | December 19, 2017 |
| Recalling firm | DeRoyal Industries Inc |
| Firm location | Powell, TN |
| Affected scope | 226 kits |
| Distribution | Distributed to states of: CA and MO. |
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-0334-2018) 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? ▼
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical. Recalled by DeRoyal Industries Inc. Units affected: 226 kits.
Why was this product recalled? ▼
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0334-2018.
Where was the recalled product distributed? ▼
Distribution: Distributed to states of: CA and MO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0334-2018) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 January 24, 2018. 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.