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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68493

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

15 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 15

Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

Z-2003-2014
Recall number
Z-2003-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 400340, Lot numbers: 082127, 085127, 088127, 092127, 094127, 097127, 100127, 102127, 104127, 106127, 108127, 137127, 141127, 145127, 148127, 154127, 156127, 159127, 161127, 163127, 194127, 198127, 200127, 204127, 207127, 209127, 223127, 224127, 226127, 228127, 230127, 232127, 239127, 241127, 243127, 245127, 246127, 248127, 250127, 252127, 256127, 259127, 263127, 266127, 269127, 289127, 290127, 292127, 307127, 309127, 312127, 314127, 316127, 318127, 320127, 322127, 338127, 340127, 345127, 350127, 353127, 356127, 359127, 386127, 388127, 390127, 392127, 395127, 399127, 403127, 406127, 410127, 414127, 419127, 421127, 430127, 432127, 447127, 450127, 453127, 456127, 459127, 462127, 465127, 467127, 477127, 478127, 481127, 483127, 486127, 487127, 489127, 491127, 493127, 496127, 516127, 577127 & 580127.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 2 of 15

Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .

Z-2004-2014
Recall number
Z-2004-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 400640, Lot numbers: 021126, 022126, 030126, 031126, 032126, 033126, 034126, 037126, 038126, 039126, 040126, 047126, 048126, 049126, 050126, 051126, 052126, 059126, 060126, 061126, 066126, 067126, 072126, 073126, 074126, 081126, 082126, 083126, 084126, 085126, 093126, 094126, 095126, 096126, 100126, 101126, 102126, 103126, 104126, 109126, 110126, 116126, 117126, 118126, 119126, 125126, 126126, 127126 & 151126.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 3 of 15

Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor

Z-2005-2014
Recall number
Z-2005-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 001-40J, Lot numbers: 001129 & 002129.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 4 of 15

Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2006-2014
Recall number
Z-2006-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 003-40, Lot numbers: 088137, 093127, 095127, 096127, 098127, 099127, 101127, 103127, 105127, 107127, 111127, 112127, 113127, 114127, 115127, 116127, 117127, 118127, 119127, 120127, 121127, 122127, 123127, 124127, 125127, 126127, 127127, 128127, 129127, 130127, 131127, 132127, 133127, 134127, 135127, 136127, 138127, 140127, 143127, 144127, 146127, 147127, 149127, 150127, 151127, 152127, 153127, 158127, 160127, 162127, 164127, 165127, 166127, 167127, 168127, 169127, 170127, 171127, 172127, 173127, 175127, 176127, 178127, 179127, 180127, 182127, 183127, 185127, 186127, 187127, 188127, 189127, 190127, 191127, 192127, 193127, 196127, 197127, 199127, 201127, 202127, 203127, 205127, 206127, 208127, 210127, 212127, 214127, 216127, 218127, 219127, 220127, 221127, 234127, 235127 , 237127, 240127, 242127, 258127, 262127, 265127, 268127, 271127, 273127, 275127, 278127, 279127, 280127, 281127, 282127, 283127, 284127, 285127, 286127, 294127, 295127, 296127, 297127, 298127, 299127, 301127, 302127, 303127, 305127, 306127, 308127, 310127, 311127, 319127, 321127, 323127, 324127, 325127, 326127, 327127, 328127, 329127, 330127, 331127, 332127, 342127, 344127, 346127, 348127, 349127, 351127, 352127, 354127, 355127, 357127, 358127, 360127, 361127, 369127, 370127, 372127, 373127, 374127, 375127, 377127, 378127, 380127, 381127, 383127, 394127, 397127, 400127, 402127, 407127, 408127, 409127, 411127, 412127, 416127, 418127, 420127, 439127, 440127, 441127, 442127, 443127, 444127, 446127, 448127, 449127, 451127, 452127, 454127, 455127, 457127, 460127, 461127, 463127, 469127, 472127, 475127, 476127, 479127, 480127, 482127, 484127, 494127, 498127, 499127, 501127, 502127, 503127, 504127, 505127, 506127, 507127, 508127, 510127, 546127, 547127 & 548127..

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 5 of 15

Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2007-2014
Recall number
Z-2007-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 003-40C, Lot numbers: 109127, 155127, 157127, 174127, 195127, 222127, 277127, 335127, 337127, 384127, 422127, 425127, 497127 & 500127.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 6 of 15

Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2008-2014
Recall number
Z-2008-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 003-40F, Lot numbers: 046127, 049127, 052127, 053127, 055127, 056127, 058127, 059127, 061127, 062127, 065127, 066127, 068127, 069127, 071127, 072127, 074127, 211127, 213127, 215127, 217127, 233127, 236127, 238127, 244127, 247127, 249127, 251127, 253127, 257127, 260127, 261127, 264127, 267127, 270127, 272127, 274127, 276127, 288127, 300127, 304127, 313127, 315127, 317127, 333127, 334127, 336127, 339127, 341127, 343127, 368127, 371127, 376127, 379127, 382127, 396127, 398127, 401127, 405127, 433127, 435127, 438127, 464127, 466127, 468127, 470127, 471127, 473127, 474127, 485127, 488127, 490127, 492127, 495127, 513127 & 518127.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 7 of 15

Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2009-2014
Recall number
Z-2009-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 003-40J, Lot numbers: 177127, 181127, 184127, 225127, 227127, 229127, 231127, 254127, 287127, 291127, 293127, 363127, 364127, 365127, 366127, 367127, 385127, 387127, 389127, 391127, 393127, 423127, 424127, 429127, 431127, 434127, 436127, 437127 & 445127.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 8 of 15

Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2010-2014
Recall number
Z-2010-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 005-40, Lot numbers: 001125, 002125, 003125, 004125, 005125, 006125, 007125, 008125, 009125, 010125, 011125, 012125, 013125, 014125, 015125, 016125, 017125, 019125, 020125, 021125, 022125, 023125, 024125, 025125, 026125 & 032125.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 9 of 15

Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2011-2014
Recall number
Z-2011-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 006-40C, Lot numbers: 029126, 036126, 065126, 071126, 076126 & 091126.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 10 of 15

Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2012-2014
Recall number
Z-2012-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 006-40, Lot numbers: 041126, 042126, 043126, 044126, 053126, 054126, 055126, 056126, 057126, 058126, 068126, 069126, 070126, 075126, 077126, 078126, 079126, 086126, 087126, 088126, 089126, 090126, 097126, 111126, 120126, 121126, 122126, 123126, 128126, 155126 & 156126.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 11 of 15

Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2013-2014
Recall number
Z-2013-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 006-40F, Lot numbers: 020126, 046126, 062126, 064126, 080126, 092126, 107126, 108126 & 115126.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 12 of 15

Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2014-2014
Recall number
Z-2014-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 006-40J, Lot numbers: 028126, 035126, 045126, 063126, 098126, 105126 & 106126.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 13 of 15

Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2015-2014
Recall number
Z-2015-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 4000040, Lot number: AG14.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 14 of 15

Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2016-2014
Recall number
Z-2016-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 000-40, Lot numbers: AA19, AB12, AC20, AE03, AE18, AE21, AF09, AF16, AG10, AG12 & AH11.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.

device · product 15 of 15

Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor.

Z-2017-2014
Recall number
Z-2017-2014
Initiated
June 05, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7,758,650 ea. (total for all types listed)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Code information

Product Code: 000-40F, Lot numbers: AA05 & AC01.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.