Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 24, 2021
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
There is a potential presence of particulate matter in the D-Vial.
The recall
Sirtex Medical Limited issued this moderate-severity FDA Devices recall — There is a potential presence of particulate matter in the D-Vial..
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- March 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1275-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1275-2021) was formally reported on March 24, 2021, with the manufacturer initiating the action on February 22, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Sirtex Medical Limited is listed as the recalling firm, operating out of North Ryde, New South Wales, N/A. Federal records list the affected scope as 3310.
The documented reason for this recall is: There is a potential presence of particulate matter in the D-Vial. Distribution data in the federal record shows the product reached: US Nationwide distribution.. 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, 6 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 — 27,303 medical devices recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
3310
Related Recalls
6
6 from same agency
Product description
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Reason for recall
There is a potential presence of particulate matter in the D-Vial.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1275-2021 |
| Date reported | March 24, 2021 |
| Date initiated | February 22, 2021 |
| Recalling firm | Sirtex Medical Limited |
| Firm location | North Ryde, New South Wales, N/A |
| Affected scope | 3310 |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.. Recalled by Sirtex Medical Limited. Units affected: 3310.
Why was this product recalled? ▼
There is a potential presence of particulate matter in the D-Vial.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1275-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1275-2021) 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.
FDA Devices Moderate
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18
FDA Devices Low
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Patient Care, Inc. · 2026-03-18
FDA Devices Moderate
GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory · 2026-03-18
FDA Devices Moderate
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter Mishima K.K. · 2026-03-18
FDA Devices Critical
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…
Trividia Health, Inc. · 2026-03-18
Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 24, 2021.
- 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.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).