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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77282

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

Open FDA event record

Event summary

Timeline bucket
May 10, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ConvaTec, 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

18 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 18

Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;

Z-2228-2017
Recall number
Z-2228-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
816,709

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

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

Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.

Code information

Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 2 of 18

Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM

Z-2229-2017
Recall number
Z-2229-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 105631

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 3 of 18

Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM

Z-2230-2017
Recall number
Z-2230-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number (Product Code 106-E), 100152, 102095, 102154, 103122, 103159, 103385, 103527, 103558, 104009, 104321, 104322, 104328, 104701, 104975, 105569, 105656, 1045675; (Product Code 3226MM) 100720, 101141; (Product Code 9108MM) 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 4 of 18

Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM

Z-2231-2017
Recall number
Z-2231-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100721, 100733, 104106, 104798, 109824

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 5 of 18

Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E

Z-2232-2017
Recall number
Z-2232-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100454, 100734, 101053, 101121, 101607, 101665, 101999, 102352, 102726, 102766, 102785, 103179, 103254, 103529, 104103, 104457, 104653, 104706, 104799, 105213, 105283, 105315, 105451, 105676, 109186

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 6 of 18

Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM

Z-2233-2017
Recall number
Z-2233-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 7 of 18

Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM

Z-2234-2017
Recall number
Z-2234-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100919, 101880

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 8 of 18

Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E

Z-2235-2017
Recall number
Z-2235-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number  100163, 100464, 101671, 102011, 102397, 102787, 102856, 103850, 104901

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 9 of 18

Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001

Z-2236-2017
Recall number
Z-2236-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number (Product Code 3104MM) 103665; (Product Coe 9104-E) 100130, 101056, 101638, 102066, 104977; (Product Code PMD06001) 100914

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 10 of 18

Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E

Z-2237-2017
Recall number
Z-2237-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100272, 100465, 101132, 101616, 101994, 102398, 102788, 102935, 103192, 103384, 103445, 103851, 103908, 104078, 104902, 104947, 105189, 105441, 105935

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 11 of 18

Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003

Z-2238-2017
Recall number
Z-2238-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number (Product Code 3108-E) 100132, 104079, 105936; (Product Code 3108MM) 103715; (Product Code 86-106E) 100056, 101452, 101725, 102695, 103006, 104041, 104198, 104634, 104969, 105687; (Product Code 86-108E) 100057, 100200, 101453, 101726, 102080, 102477, 102566, 102696, 103005, 103549, 104042, 104199, 104450, 104694, 104847, 104971, 105596, 105688; (Product Code LM-86-106) 100138, 102215, 102866, 104160, 105169; (Product Code PMD06002) 100551; (Product Code PMD06003) 100550

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 12 of 18

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

Z-2239-2017
Recall number
Z-2239-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number  (Product Code 3224-E) 105215; (Product Code 3226-E) 100497, 100748, 101140, 102282, 102400, 102727, 102858, 103188, 103273, 103300, 103853, 104081, 104654, 104889, 105065, 105190, 105216, 13-34

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 13 of 18

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E

Z-2240-2017
Recall number
Z-2240-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number  100214, 100316, 100467, 101619, 102605, 102728, 103190, 103451, 103852, 104083, 104905, 105142

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 14 of 18

Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM

Z-2241-2017
Recall number
Z-2241-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number  104906, 105181

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 15 of 18

Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

Z-2242-2017
Recall number
Z-2242-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number  100071, 100242, 100253, 100601, 100749, 100811, 101143, 101480, 102711, 103195, 103275, 103324, 105511, 105571, 105660

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 16 of 18

Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106

Z-2243-2017
Recall number
Z-2243-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number (Product Code 86-3226E) 100050, 100196, 102698, 103003, 104062, 104331, 104424, 104928, 105597; (Product Code PMD06009) 100574; (Product Code PMD06106) 100581

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 17 of 18

Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA

Z-2244-2017
Recall number
Z-2244-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number (Product Code 9106-E) 100168, 101193, 101896; (Product Code 9108-E) 102143, 103119, 103378, 104273, 104839, 104879, 105224; (Product Code ZRNRMA) 101060, 103355, 104768, 105655

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

device · product 18 of 18

Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E

Z-2245-2017
Recall number
Z-2245-2017
Initiated
May 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

No assignment exists because the official recall reason is blank.

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

Unavailable

Code information

Lot Number 100150, 100478, 100775, 101054, 101057, 101700, 101705, 103210, 103379, 103762, 105485

Distribution pattern

CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam

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