FDAClass II · Medical device · Recall Z-2474-2026 · Recalled June 24, 2026
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall — ConMed Corporation
Agency report date: June 24, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
- Product named
- ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip
- Company / brand
- ConMed
- Lot / serial / date codes
- Catalog Number: iAS12-100LPI. UDI-DI: 10845854045640. Lot Numbers: 2025082210, 202502265, 202601074, 202512034, 202601084, 202512194, 202512184, 202512204, 202512224, 202512024, 2026010610, 2025100710, 202512094, 202512174, 2025121810, 202510214, 2026010511, 202510024, 202510104, 202510224, 202510084, 2025121710, 202510064, 202512104, 202512164, 202512064, 202512084, 202512054, 202512044, 202512154, 202510014, 202511144, 202511254, 202511264, 202510074, 202510144, 202511124, 202509094, 202509194, 202509294, 2025093010, 202509304, 202511134, 202511194, 202509084, 2025102310, 202510294, 202510304, 202510314, 202511046, 202511114, 2025101510, 202511154, 202511184, 202509184, 202510284, 202509174, 202511014, 202511044, 202511054, 202509044, 202509164, 202510274, 2025082210, 2025101310, 202509224, 2025092910, 202510134, 2025100610, 202508194, 202508234, 202509054, 202508184, 2025082110, 202508224, 202508144, 2025082010, 2025081110, 202508114, 202508134, 202508154, 202508054, 202508074, 2025080610, 202508254, 202507304, 202508064, 202507214, 202507224, 2025072410, 2025072510, 2025072810, 2025072910, 202507184, 202507284, 2025070910, 2025071010, 202507174, 202507154, 202507164, 2025072310, 2025071410, 2025070810, 202507084, 202507094, 202507144, 2025070710, 202507014, 202506234, 202507044, 2025070210, 202507024, 2025062310, 2025060610, 202506064, 2025060910, 202506094, 202506184, 2025060510, 202506054, 2025060410, 202507045, 202506044, 202506174, 202506034, 202506194, 2025062010, 202506204, 2025052210, 202505264, 2025050910, 202505104, 202506074, 2025061010, 202505204, 2025052110, 2025052310, 202505274, 2025050810, 202505084, 202505134, 2025051210, 202505224, 202505234, 2025052710, 202505094, 2025042910, 2025050710, 202505074, 202505214, 2025042810, 202505064, 202505124, 202504154, 202503194, 202504244, 202504254, 202504284, 202504114, 202504116, 202504144, 202504095, 202503125, 202503184, 202503185, 202502245, 202502255, 2025042210, 202503254, 202503265, 202502284, 202502285, 202503115, 202503276, 202503296, 202503274, 202503284, 202503314, 202503275, 202503286, 202503264, 202503266, 202503145, 202503255, 202503034, 202503035, 202503045, 202503055, 202503105, 2024121711, 202502134, 202502175, 202502135, 202502125, 202502184, 202502056, 202407174, 202411125, 202504015, 202509024, 202506126, 2025061910, 2025052610, 2025042510, 202504084, 202411304, 202412206, 202503256, 202509234, 2024111110, 202411166, 2024111811, 2024120511, 202412196, 202411054, 202411085, 202410174, 202411135, 202411296, 202412064, 202410164, 2024110611, 202409264, 202409134, 202411154, 202407276, 202407194, 202409175, 202409254, 202409135, 202408024, 202407235, 202407256, 202408235, 202406185, 202406186, 202407034, 202407085, 202407236, 2025062410, 2024111210, 202502195, 2024121810, 2024111810, 202407045, 202409184, 2024110810, 202509284, 202406276, 2025042410, 202503285, 202411115, 202412216, 2024110610, 202412034, 202410074, 202410184, 202410215, 2024110710, 202408085, 202407254, 202407055, 202407314, 202407095, 202502185, 202409194, 2025051310, 202511034, 202410155, 202409036, 202407316, 202505236, 202502215, 202407184, 202409304, 2024120411, 2024120311, 202408016, 202409195, 202412036, 2025081210, 202407035, 202408055, 2024121811, 202407195, 202501186, , 202410085, 202504294, 202502115, 202410224, 2024120410, 202509034, 202412056, 2024072510, 202409124, 202410025, 202407305, 202501096, 202411124, 202410154, 202407036, 202410024, 202407096, 202411185, 202407246, 202408086, 202407196, 202406275, 2026010710, 2024111510, 202412164, 202412035, 202407056, 202411155. *OUS added 06/10/2026 expansion: 202412165, 2024121611, 2024110810, 202512164, 202512174, 202509174, 202510284, 202509304, 202508074, 202508194, 202508184, 202507304, 202506204, 2025062010, 202506174, 202506054, 2025060510, 202507174, 202507184, 202503296, 202503314, 2025042910, 202505074, 2025061010, 202506074, 202412026, 202411306, 202411284, 202503035, 202502245, 202412044, 202502284, 202410144, 202410114, 202408306, 202411114, 2024121710, 2024121711, 202501035, 202412195, 202412065, 202412054, 202511184, 202511044, 202511054, 202406275, 202406146, 202406175, 202409125, 202409135, 202407184, 202407185, 202407195, 202407194, 2025072910, 2025072310, 202504114, 2025050810, 202501075, 202411134, 202411145, 202407025, 202409024, 2025121810, 202506094, 202411074, 202508224, 202508054, 2025071410, 202507144, 202503284, 202504244, 2025060310, 202505104, 2025050910, 202504284, 202412035, 202501176, 202502265, 202501046, 202502125, 202411156, 2024121610, 2024111111, 2024121811, 202411185, 202410165, 202409305, 202410105, 202410024, 2024110710, 202412185, 202411085, 202412055, 202407036, 202407265, 202409205, 202407165, 202409124, 202409025, 202407094, 202507014, 2025042210, 202505084, 202512024, 202510024, 202512224, 2025100610, 202508234, 202511124, 202509294, 2025070710, 202503194, 202505094, 202502054, 202503034, 2024111510, 202410154, 202512054, 202407224, 202506064, 202512064, 202512194, 202510304, 202511154, 2025102310, 2025052710, 202502285, 2024121410, 202501175, 202410175, 202410084, 202409175, 202406156, 202503276, 202512094, 202509084, 202411065, 202512034, 202510214, 202511014, 202510314, 202411115, 202411285, 202407084, 202411286, 202512084, 202511194, 202503265, 202412196, 202502145, 202409204, 202511114, 202507224, 202508114, 2025070210, 202506184, 2025060410, 202506034, 202506044, 202503055, 202501306, 202411064, 202410094, 202407045, 202406196, 202407315, 202407066, 202409114, 202510064, 202509184, 202510074, 2025060910, 202510224, 2025082110, 202504116, 202505274, 202502016, 202410025, 202502274, 202412174, 2025101510, 2025100710, 202512204, 202511254, 202503145, 202412184, 202407096, 202406264, 202409174, 202504144, 202412164, 202502254, 202412186, 202507154, 202505124, 202501065, 202408215, 202412146, 202504095, 202506194, 2024121011, 202410155, 202409194, 202409185, 202409184, 202407054, 2025082210, 202507284, 2025072510, 2025072410, 202503045, 202511264, 202510104, 202512184, 202509054, 202510294, 202508254, 202509044, 202508144, 202507024, 202507044, 202507045, 2025060610, 202503255, 202503254, 202503184, 202503185, 202505064, 202505224, 202505134, 2025052110, 202505204, 202505214, 202501314, 202501216, 202501186, 202501064, 202408276, 202408226, 202411294, 2024120411, 202412036, 202407276, 202407305, 202407306, 202407314, 202407044, 202407046, 202502045, 202510274, 202508154, 202510084, 202511134, 202411275, 202412145, 2025052210, 202504154, 2025042810, 202503275, 202501174, 202407034, 202502174, 202501074, 202509194, 202505264, 2025081110, 202407155, 2025121710, 202512104, 202512154, 202509094, 202509224, 202511144, 202511046, 202511064, 202507214, 2025072810, 2025080610, 202508064, 202508134, 202506234, 2025062310, 202507164, 202502255, 202503125, 202503115, 202503105, 202503286, 202504254, 2024111511, 202502184, 202502134, 202502175, 202502135, 2024120410, 202412064, 202411084, 202411075, 202410035, 2024121810, 202411144, 202407035, 202409036, 202407235, 2024072510, 202407254, 202407245, 202407255, 202407095, 202407164, 202510014, 2025082010, 2025092910, 202510144, 202501296, 202406276, 202412056, 202506115, 2025061810, 2025061910, 2025042510, 202503285, 202503315, 2024111810, 202501096, 202501316, 202509024, 202509034, 202510315, 202510134, 2025052610, 202409134, 2025101310, 2025081210, 2025051310, 202408024, 202407174, 202407256, 202409254, 202407246, 202410085, 202411135, 202411154, 202410184, 2025052310, 202407085, 202406186, 202409195, 202504015, 2024120511, 202411125, 202509234, 202410224, 202601084, 202509164, 202507084, 2025042410, 202505236, 202504084, 202502215, 2024111110, 202410215, 202408016, 202407055, 202407316, 202504294, 202601074, 202505234, 2025093010, 202511034, 202502264, 202502195, 202411124, 202411166, 202410164, 202406185, 2025050710, 202410074, 202506126, 2025070810, 202411296, 202412034, 202411054, 2024111210, 202408235, 202409264, 202509284, 202502115, 2024110610, 202410174, 202502185, 202410115, 202408086, 202410145, 202406286, 202409115, 202408236, 202408316, 202504106, 202409265, 202502044, 2024111811, 202410104, 202410095, 202407206, 202407295, 202407225, 202408055, 202408085, 202512044, 202504014, 202510234, 2025051210, 202502056, 2026010511, 2026010610, 2025071010, 202507094, 2025070910, 202503266, 202503264, 202503274, 202501204, 202409275, 202409274, 202411184, 202411155, 202408285, 202408096, 202408054, 202408066, 202410214, 202410185, 202510114, 202510094, 202511055, 202509204, 202509154, 2025072610, 2025062410, 202506216, 202504104, 202504094, 202504086, 202504085, 202504075, 202504026, 202504024, 202504016, 202503144, 2025042310, 202504164, 202503135, 202503134, 202503124, 202503054, 202503044, 202501315, 202501205, 202412045, 202412024, 202412025, 2024120311, 202501305, 202501304, 202501295, 202501294, 202501285, 202501284, 202501215, 202412205, 202412204, 202501214, 202411305, 202411295, 202408214, 202410045, 202410044, 202410034, 202409304, 202409245, 202409244, 202409235, 202409234, 202408305, 202408284, 202410075, 2024110711, 202407244, 202407236, 202407234, 202407175, 202406144, 202408025, 202408064, 202406274, 202406145, 202406184, 202406194, 202406265, 202406174, 202407176, 202407186, 202408265, 202407196, 202407304, 202408264, 202408274, 202408075, 202407056. Manufactured from 14 June 2024 to 12 January 2026.
- Distribution
- Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .
Agency product description and boundaries
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Potential for overpressure alerts.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2474-2026
- Brand
- All ConMed recalls
- Classification
- Class II
- Units affected
- 147,013 packs (882,078 eaches)
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Affected products
Companies & origin
- Recalling firm location
- Utica, NY, United States
- Firm address
- 525 French Rd, 13502-5945
Identifying details (verbatim from the notice)
- Product codes / lots
- Catalog Number: iAS12-100LPI. UDI-DI: 10845854045640. Lot Numbers: 2025082210, 202502265, 202601074, 202512034, 202601084, 202512194, 202512184, 202512204, 202512224, 202512024, 2026010610, 2025100710, 202512094, 202512174, 2025121810, 202510214, 2026010511, 202510024, 202510104, 202510224, 202510084, 2025121710, 202510064, 202512104, 202512164, 202512064, 202512084, 202512054, 202512044, 202512154, 202510014, 202511144, 202511254, 202511264, 202510074, 202510144, 202511124, 202509094, 202509194, 202509294, 2025093010, 202509304, 202511134, 202511194, 202509084, 2025102310, 202510294, 202510304, 202510314, 202511046, 202511114, 2025101510, 202511154, 202511184, 202509184, 202510284, 202509174, 202511014, 202511044, 202511054, 202509044, 202509164, 202510274, 2025082210, 2025101310, 202509224, 2025092910, 202510134, 2025100610, 202508194, 202508234, 202509054, 202508184, 2025082110, 202508224, 202508144, 2025082010, 2025081110, 202508114, 202508134, 202508154, 202508054, 202508074, 2025080610, 202508254, 202507304, 202508064, 202507214, 202507224, 2025072410, 2025072510, 2025072810, 2025072910, 202507184, 202507284, 2025070910, 2025071010, 202507174, 202507154, 202507164, 2025072310, 2025071410, 2025070810, 202507084, 202507094, 202507144, 2025070710, 202507014, 202506234, 202507044, 2025070210, 202507024, 2025062310, 2025060610, 202506064, 2025060910, 202506094, 202506184, 2025060510, 202506054, 2025060410, 202507045, 202506044, 202506174, 202506034, 202506194, 2025062010, 202506204, 2025052210, 202505264, 2025050910, 202505104, 202506074, 2025061010, 202505204, 2025052110, 2025052310, 202505274, 2025050810, 202505084, 202505134, 2025051210, 202505224, 202505234, 2025052710, 202505094, 2025042910, 2025050710, 202505074, 202505214, 2025042810, 202505064, 202505124, 202504154, 202503194, 202504244, 202504254, 202504284, 202504114, 202504116, 202504144, 202504095, 202503125, 202503184, 202503185, 202502245, 202502255, 2025042210, 202503254, 202503265, 202502284, 202502285, 202503115, 202503276, 202503296, 202503274, 202503284, 202503314, 202503275, 202503286, 202503264, 202503266, 202503145, 202503255, 202503034, 202503035, 202503045, 202503055, 202503105, 2024121711, 202502134, 202502175, 202502135, 202502125, 202502184, 202502056, 202407174, 202411125, 202504015, 202509024, 202506126, 2025061910, 2025052610, 2025042510, 202504084, 202411304, 202412206, 202503256, 202509234, 2024111110, 202411166, 2024111811, 2024120511, 202412196, 202411054, 202411085, 202410174, 202411135, 202411296, 202412064, 202410164, 2024110611, 202409264, 202409134, 202411154, 202407276, 202407194, 202409175, 202409254, 202409135, 202408024, 202407235, 202407256, 202408235, 202406185, 202406186, 202407034, 202407085, 202407236, 2025062410, 2024111210, 202502195, 2024121810, 2024111810, 202407045, 202409184, 2024110810, 202509284, 202406276, 2025042410, 202503285, 202411115, 202412216, 2024110610, 202412034, 202410074, 202410184, 202410215, 2024110710, 202408085, 202407254, 202407055, 202407314, 202407095, 202502185, 202409194, 2025051310, 202511034, 202410155, 202409036, 202407316, 202505236, 202502215, 202407184, 202409304, 2024120411, 2024120311, 202408016, 202409195, 202412036, 2025081210, 202407035, 202408055, 2024121811, 202407195, 202501186, , 202410085, 202504294, 202502115, 202410224, 2024120410, 202509034, 202412056, 2024072510, 202409124, 202410025, 202407305, 202501096, 202411124, 202410154, 202407036, 202410024, 202407096, 202411185, 202407246, 202408086, 202407196, 202406275, 2026010710, 2024111510, 202412164, 202412035, 202407056, 202411155. *OUS added 06/10/2026 expansion: 202412165, 2024121611, 2024110810, 202512164, 202512174, 202509174, 202510284, 202509304, 202508074, 202508194, 202508184, 202507304, 202506204, 2025062010, 202506174, 202506054, 2025060510, 202507174, 202507184, 202503296, 202503314, 2025042910, 202505074, 2025061010, 202506074, 202412026, 202411306, 202411284, 202503035, 202502245, 202412044, 202502284, 202410144, 202410114, 202408306, 202411114, 2024121710, 2024121711, 202501035, 202412195, 202412065, 202412054, 202511184, 202511044, 202511054, 202406275, 202406146, 202406175, 202409125, 202409135, 202407184, 202407185, 202407195, 202407194, 2025072910, 2025072310, 202504114, 2025050810, 202501075, 202411134, 202411145, 202407025, 202409024, 2025121810, 202506094, 202411074, 202508224, 202508054, 2025071410, 202507144, 202503284, 202504244, 2025060310, 202505104, 2025050910, 202504284, 202412035, 202501176, 202502265, 202501046, 202502125, 202411156, 2024121610, 2024111111, 2024121811, 202411185, 202410165, 202409305, 202410105, 202410024, 2024110710, 202412185, 202411085, 202412055, 202407036, 202407265, 202409205, 202407165, 202409124, 202409025, 202407094, 202507014, 2025042210, 202505084, 202512024, 202510024, 202512224, 2025100610, 202508234, 202511124, 202509294, 2025070710, 202503194, 202505094, 202502054, 202503034, 2024111510, 202410154, 202512054, 202407224, 202506064, 202512064, 202512194, 202510304, 202511154, 2025102310, 2025052710, 202502285, 2024121410, 202501175, 202410175, 202410084, 202409175, 202406156, 202503276, 202512094, 202509084, 202411065, 202512034, 202510214, 202511014, 202510314, 202411115, 202411285, 202407084, 202411286, 202512084, 202511194, 202503265, 202412196, 202502145, 202409204, 202511114, 202507224, 202508114, 2025070210, 202506184, 2025060410, 202506034, 202506044, 202503055, 202501306, 202411064, 202410094, 202407045, 202406196, 202407315, 202407066, 202409114, 202510064, 202509184, 202510074, 2025060910, 202510224, 2025082110, 202504116, 202505274, 202502016, 202410025, 202502274, 202412174, 2025101510, 2025100710, 202512204, 202511254, 202503145, 202412184, 202407096, 202406264, 202409174, 202504144, 202412164, 202502254, 202412186, 202507154, 202505124, 202501065, 202408215, 202412146, 202504095, 202506194, 2024121011, 202410155, 202409194, 202409185, 202409184, 202407054, 2025082210, 202507284, 2025072510, 2025072410, 202503045, 202511264, 202510104, 202512184, 202509054, 202510294, 202508254, 202509044, 202508144, 202507024, 202507044, 202507045, 2025060610, 202503255, 202503254, 202503184, 202503185, 202505064, 202505224, 202505134, 2025052110, 202505204, 202505214, 202501314, 202501216, 202501186, 202501064, 202408276, 202408226, 202411294, 2024120411, 202412036, 202407276, 202407305, 202407306, 202407314, 202407044, 202407046, 202502045, 202510274, 202508154, 202510084, 202511134, 202411275, 202412145, 2025052210, 202504154, 2025042810, 202503275, 202501174, 202407034, 202502174, 202501074, 202509194, 202505264, 2025081110, 202407155, 2025121710, 202512104, 202512154, 202509094, 202509224, 202511144, 202511046, 202511064, 202507214, 2025072810, 2025080610, 202508064, 202508134, 202506234, 2025062310, 202507164, 202502255, 202503125, 202503115, 202503105, 202503286, 202504254, 2024111511, 202502184, 202502134, 202502175, 202502135, 2024120410, 202412064, 202411084, 202411075, 202410035, 2024121810, 202411144, 202407035, 202409036, 202407235, 2024072510, 202407254, 202407245, 202407255, 202407095, 202407164, 202510014, 2025082010, 2025092910, 202510144, 202501296, 202406276, 202412056, 202506115, 2025061810, 2025061910, 2025042510, 202503285, 202503315, 2024111810, 202501096, 202501316, 202509024, 202509034, 202510315, 202510134, 2025052610, 202409134, 2025101310, 2025081210, 2025051310, 202408024, 202407174, 202407256, 202409254, 202407246, 202410085, 202411135, 202411154, 202410184, 2025052310, 202407085, 202406186, 202409195, 202504015, 2024120511, 202411125, 202509234, 202410224, 202601084, 202509164, 202507084, 2025042410, 202505236, 202504084, 202502215, 2024111110, 202410215, 202408016, 202407055, 202407316, 202504294, 202601074, 202505234, 2025093010, 202511034, 202502264, 202502195, 202411124, 202411166, 202410164, 202406185, 2025050710, 202410074, 202506126, 2025070810, 202411296, 202412034, 202411054, 2024111210, 202408235, 202409264, 202509284, 202502115, 2024110610, 202410174, 202502185, 202410115, 202408086, 202410145, 202406286, 202409115, 202408236, 202408316, 202504106, 202409265, 202502044, 2024111811, 202410104, 202410095, 202407206, 202407295, 202407225, 202408055, 202408085, 202512044, 202504014, 202510234, 2025051210, 202502056, 2026010511, 2026010610, 2025071010, 202507094, 2025070910, 202503266, 202503264, 202503274, 202501204, 202409275, 202409274, 202411184, 202411155, 202408285, 202408096, 202408054, 202408066, 202410214, 202410185, 202510114, 202510094, 202511055, 202509204, 202509154, 2025072610, 2025062410, 202506216, 202504104, 202504094, 202504086, 202504085, 202504075, 202504026, 202504024, 202504016, 202503144, 2025042310, 202504164, 202503135, 202503134, 202503124, 202503054, 202503044, 202501315, 202501205, 202412045, 202412024, 202412025, 2024120311, 202501305, 202501304, 202501295, 202501294, 202501285, 202501284, 202501215, 202412205, 202412204, 202501214, 202411305, 202411295, 202408214, 202410045, 202410044, 202410034, 202409304, 202409245, 202409244, 202409235, 202409234, 202408305, 202408284, 202410075, 2024110711, 202407244, 202407236, 202407234, 202407175, 202406144, 202408025, 202408064, 202406274, 202406145, 202406184, 202406194, 202406265, 202406174, 202407176, 202407186, 202408265, 202407196, 202407304, 202408264, 202408274, 202408075, 202407056. Manufactured from 14 June 2024 to 12 January 2026.
- Distribution
- Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .
- Firm notified the public via
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- FDA event ID
- 98854
- Recall initiated
- May 14, 2026
- FDA classified
- June 17, 2026
- FDA report date
- June 24, 2026
Related recalls
Other medical device recalls from around the same time
- Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
- Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
- Impella CP Set with SmartAssist recall — Abiomed, Inc.FDA · June 24, 2026
- Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
- Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 22, 2026 at 6:00 PM UTC.