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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92301

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 22, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

Z-1908-2023
Recall number
Z-1908-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2605742; UDI-DI: 00884450398166

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 2 of 13

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only

Z-1909-2023
Recall number
Z-1909-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2605742; UDI-DI: 00884450398166

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 3 of 13

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only

Z-1910-2023
Recall number
Z-1910-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
175 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2538438, I2614180, I2623234/ UDI: 00884450394892

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 4 of 13

Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

Z-1911-2023
Recall number
Z-1911-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
670 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2533611, I2546597, I2559292, I2548163 & I2578001; UDI-DI: 00884450394908

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 5 of 13

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

Z-1912-2023
Recall number
Z-1912-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
156 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 6 of 13

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

Z-1913-2023
Recall number
Z-1913-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
524 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2548172, I2568218, I2553914, I2614174, I2638785, I2559299; UDI-DI: 00884450394915

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 7 of 13

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

Z-1914-2023
Recall number
Z-1914-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
436 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2559297, I2564678, I2553915, I2614173, I2568219; UDI-DI: 00884450394939

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 8 of 13

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

Z-1915-2023
Recall number
Z-1915-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
1054 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231; UDI-DI: 00884450394946

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 9 of 13

Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

Z-1916-2023
Recall number
Z-1916-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
2559 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 10 of 13

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

Z-1917-2023
Recall number
Z-1917-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2587050; UDI-DI: 00884450488447

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 11 of 13

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only

Z-1918-2023
Recall number
Z-1918-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2578012; UDI-DI: 00884450488539

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 12 of 13

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only

Z-1919-2023
Recall number
Z-1919-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2587055; UDI-DI: 00884450488416

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

device · product 13 of 13

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only

Z-1920-2023
Recall number
Z-1920-2023
Initiated
April 22, 2023
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential that valve assemblies will not open. preventing fluid from draining.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential that valve assemblies will not open. preventing fluid from draining.

Code information

Lot # I2559306; UDI-DI: 00884450488492

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.