Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 17, 2018
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sterilmed, Inc. recalled Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascula… - a moderate-severity action.
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascula… was recalled by Sterilmed, Inc. in October 17, 2018. Reason: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for bi…. Check the official notice for the remedy. Verify recall #Z-0090-2019 with the FDA Devices before acting.
The recall
Sterilmed, Inc. issued this moderate-severity FDA Devices recall-Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for bi….
- Moderate
- severity level
- 218 units
- affected scope
- Class II
- classification
- October 17, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0090-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0090-2019) was formally reported on October 17, 2018, with the manufacturer initiating the action on September 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Sterilmed, Inc. is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 218 units.
The documented reason for this recall is: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of CA, CO, MN, and WA.. 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
218 units
Related Recalls
6
3 from same agency
Product description
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Reason for recall
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0090-2019 |
| Date reported | October 17, 2018 |
| Date initiated | September 17, 2018 |
| Recalling firm | Sterilmed, Inc. |
| Firm location | Plymouth, MN |
| Affected scope | 218 units |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, MN, and WA. |
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-0090-2019) 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? ▼
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324. Recalled by Sterilmed, Inc.. Units affected: 218 units.
Why was this product recalled? ▼
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2018. Severity: Moderate. Recall number: Z-0090-2019.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of CA, CO, MN, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0090-2019) 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 17, 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.