Exact FDA event identifier

Event 75554

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

Event summary

Timeline bucket: October 27, 2016
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

7 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 7

LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0381-2017

Recall number: Z-0381-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 2 of 7

FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0382-2017

Recall number: Z-0382-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 3 of 7

FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0383-2017

Recall number: Z-0383-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 4 of 7

LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0384-2017

Recall number: Z-0384-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD600, Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and 160807; Product Code: MAD700, Lot# 160111, 160129, 160141, 160209, 160233, 160316, 160329, 160403, 160431, 160502, 160520, 160604, 160624, 160634, 160712, 160809 and 160818; Product Code: MAD720, Lot# 160142, 160404, 160511, 160725 and 160909; Product Code: MAD730, Lot# 160427; Product Code: MAD730OS, Lot# 160305.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 5 of 7

LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0385-2017

Recall number: Z-0385-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD710, Lot# 160120.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 6 of 7

LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

Z-0386-2017

Recall number: Z-0386-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

device · product 7 of 7

Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

Z-0898-2017

Recall number: Z-0898-2017
Initiated: October 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: Teleflex Medical
Quantity: 2,674,650 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Code information

Product code MAD100, Batch/Lot numbers 160105, 160137, 160302, 160321, 160402, 160435, 160506, 160523, 160609, 160620, 160707, 160802, 160813; Product code MAD100OS, Batch/Lot numbers 160322, 160524, 160630; Product code MAD110, Batch/Lot numbers 160217, 160507; Product code MAD110OS, Batch/Lot numbers 160240, 160312; Product code MAD130, Batch/Lot numbers 160107, 160138, 160517; Product code MAD130OS, Batch/Lot numbers 160436, 160803; Product code MAD140, Batch/Lot numbers 160125, 160218, 160437, 160610, 160801; Product code MAD140OS, Batch/Lot numbers 160226, 160438, 160727; Product code MAD300, Batch/Lot numbers 160108, 160117, 160126, 160145, 160146, 160200, 160219, 160225, 160231, 160300, 160313, 160327, 160400, 160409, 160422, 160432, 160440, 160500, 160518, 160602, 160611, 160621, 160631, 160701, 160708, 160718, 160728, 160800, 160804, 160814, 160816, 160823; Product code MAD300B, Batch/Lot number 160410.

Distribution pattern

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.