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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81021

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

Open FDA event record

Event summary

Timeline bucket
September 05, 2017
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

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

Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Z-0710-2019
Recall number
Z-0710-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
70,860

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 352 Lot Numbers: A214, A215, Z263, Z532, and Z555

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 2 of 13

Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿

Z-0711-2019
Recall number
Z-0711-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
57,336

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 552 Lot Numbers: A054, A089, A090, and Z262

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 3 of 13

Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Z-0712-2019
Recall number
Z-0712-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
21,876

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 1065 Lot Numbers: B209 and Z225

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 4 of 13

Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿

Z-0713-2019
Recall number
Z-0713-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
9,828

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 1565 Lot Number: ¿Y371

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 5 of 13

Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿

Z-0714-2019
Recall number
Z-0714-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
128,000 sold to Japan only

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 0352IMJ Lot Numbers: ¿A457, A597, B157, B236, Z589, Z655, Z656, and Z661

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 6 of 13

Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿

Z-0715-2019
Recall number
Z-0715-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
11,508 Canada only

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 0552C Lot Number: ¿Z370

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 7 of 13

Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Z-0716-2019
Recall number
Z-0716-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
16,104 Japan only

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # 0552IMJ Lot Numbers: ¿Z588 and Z597

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 8 of 13

Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿

Z-0717-2019
Recall number
Z-0717-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
16,380

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # HCS00300 Lot Number: ¿Y576

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 9 of 13

Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿

Z-0718-2019
Recall number
Z-0718-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
235,560

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 10 of 13

Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿

Z-0719-2019
Recall number
Z-0719-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
102,000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # R0059 Lot Number: ¿B360

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 11 of 13

Portex Unit Dose 15 ml Normal Saline ¿

Z-0720-2019
Recall number
Z-0720-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
357,552

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # R0159 Lot Numbers: ¿A661, B067, A526, A536, A569, and B201

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 12 of 13

Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿

Z-0721-2019
Recall number
Z-0721-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
106,000

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # UD9005 Lot Number: ¿B515

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

device · product 13 of 13

Medline Prefilled 550 ml Sterile¿¿ ¿

Z-0722-2019
Recall number
Z-0722-2019
Initiated
September 05, 2017
Classification
Class I
Status
Terminated
Quantity
54,924

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

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

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # HCS00550 Lot Numbers: ¿A092, B205, B534, and Z205

Distribution pattern

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.