Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 2018
Laparoscopy CDS
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, Inc. recalled Laparoscopy CDS - a moderate-severity action.
Laparoscopy CDS was recalled by Medline Industries, Inc. in September 12, 2018. Reason: One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit c…. Check the official notice for the remedy. Verify recall #Z-2978-2018 with the FDA Devices before acting.
The recall
Medline Industries, Inc. issued this moderate-severity FDA Devices recall-One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit c….
- Moderate
- severity level
- Class II
- classification
- September 12, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2978-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2978-2018) was formally reported on September 12, 2018, with the manufacturer initiating the action on April 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries, Inc. is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 15 kits.
The documented reason for this recall is: One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of … Distribution data in the federal record shows the product reached: CA, NM. 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
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
15 kits
Related Recalls
6
0 from same agency
Product description
Laparoscopy CDS
Reason for recall
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2978-2018 |
| Date reported | September 12, 2018 |
| Date initiated | April 12, 2017 |
| Recalling firm | Medline Industries, Inc. |
| Firm location | Waukegan, IL |
| Affected scope | 15 kits |
| Distribution | CA, NM |
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-2978-2018) 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? ▼
Laparoscopy CDS. Recalled by Medline Industries, Inc.. Units affected: 15 kits.
Why was this product recalled? ▼
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2978-2018.
Where was the recalled product distributed? ▼
Distribution: CA, NM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2978-2018) 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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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 September 12, 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.