Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2018
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Custom Healthcare Systems, Inc. recalled (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) … - a moderate-severity action.
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) … was recalled by Custom Healthcare Systems, Inc. in October 31, 2018. Reason: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product s…. Check the official notice for the remedy. Verify recall #Z-0249-2019 with the FDA Devices before acting.
The recall
Custom Healthcare Systems, Inc. issued this moderate-severity FDA Devices recall-Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product s….
- Moderate
- severity level
- Class II
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0249-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0249-2019) was formally reported on October 31, 2018, with the manufacturer initiating the action on August 13, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Custom Healthcare Systems, Inc. is listed as the recalling firm, operating out of Richmond, VA. Federal records list the affected scope as (1) 180 units (2)180 units.
The documented reason for this recall is: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility Distribution data in the federal record shows the product reached: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,. 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
(1) 180 units (2)180 units
Related Recalls
6
0 from same agency
Product description
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
Reason for recall
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0249-2019 |
| Date reported | October 31, 2018 |
| Date initiated | August 13, 2018 |
| Recalling firm | Custom Healthcare Systems, Inc. |
| Firm location | Richmond, VA |
| Affected scope | (1) 180 units (2)180 units |
| Distribution | Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina, |
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-0249-2019) 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? ▼
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269. Recalled by Custom Healthcare Systems, Inc.. Units affected: (1) 180 units (2)180 units.
Why was this product recalled? ▼
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0249-2019.
Where was the recalled product distributed? ▼
Distribution: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0249-2019) 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 October 31, 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.