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Ethicon Endo-Surgery Inc

78 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or crea recall (Z-0147-2026)Ethicon Endo-Surgery Inc2025-10-14
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product c recall (Z-1746-2025)Ethicon Endo-Surgery Inc2025-05-20
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Sta recall (Z-0834-2024)Ethicon Endo-Surgery Inc2024-01-26
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A recall (Z-0200-2020)Ethicon Endo-Surgery Inc2019-10-29
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A recall (Z-0201-2020)Ethicon Endo-Surgery Inc2019-10-29
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A recall (Z-0202-2020)Ethicon Endo-Surgery Inc2019-10-29
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A recall (Z-0203-2020)Ethicon Endo-Surgery Inc2019-10-29
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endosc recall (Z-0295-2017)Ethicon Endo-Surgery Inc2016-10-20
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex E recall (Z-0296-2017)Ethicon Endo-Surgery Inc2016-10-20
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Et recall (Z-0278-2016)Ethicon Endo-Surgery Inc2015-11-16
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiologi recall (Z-2374-2015)Ethicon Endo-Surgery Inc2015-08-26
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The ins recall (Z-1641-2015)Ethicon Endo-Surgery Inc2015-05-21
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE P recall (Z-2610-2014)Ethicon Endo-Surgery Inc2014-09-08
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with recall (Z-0149-2014)Ethicon Endo-Surgery Inc2013-11-05
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with recall (Z-0150-2014)Ethicon Endo-Surgery Inc2013-11-05
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with recall (Z-0151-2014)Ethicon Endo-Surgery Inc2013-11-05
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spa recall (Z-1772-2013)Ethicon Endo-Surgery Inc2013-07-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LI recall (Z-1775-2013)Ethicon Endo-Surgery Inc2013-07-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L recall (Z-1776-2013)Ethicon Endo-Surgery Inc2013-07-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Pro recall (Z-1777-2013)Ethicon Endo-Surgery Inc2013-07-19
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek li recall (Z-1530-2013)Ethicon Endo-Surgery Inc2013-06-11
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure i recall (Z-0918-2013)Ethicon Endo-Surgery Inc2013-03-07
Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulati recall (Z-0758-2013)Ethicon Endo-Surgery Inc2013-01-31
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorr recall (Z-0057-2013)Ethicon Endo-Surgery Inc2012-10-13
HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are ind recall (Z-1673-2012)Ethicon Endo-Surgery Inc2012-05-25
The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear C recall (Z-1627-2012)Ethicon Endo-Surgery Inc2012-05-18
ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL recall (Z-1244-2012)Ethicon Endo-Surgery Inc2012-03-21
ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C recall (Z-1245-2012)Ethicon Endo-Surgery Inc2012-03-21
ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSE recall (Z-1246-2012)Ethicon Endo-Surgery Inc2012-03-21
ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG recall (Z-1247-2012)Ethicon Endo-Surgery Inc2012-03-21
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CT recall (Z-3187-2011)Ethicon Endo-Surgery Inc2011-09-12
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; recall (Z-1068-2011)Ethicon Endo-Surgery Inc2011-02-15
FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW1 recall (Z-1069-2011)Ethicon Endo-Surgery Inc2011-02-15
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by recall (Z-0361-2011)Ethicon Endo-Surgery Inc2010-11-15
REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, recall (Z-0289-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4 recall (Z-0290-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot # recall (Z-0291-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Produc recall (Z-0292-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product recall (Z-0293-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm X recall (Z-0294-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMB recall (Z-0295-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #: recall (Z-0296-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Prod recall (Z-0297-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube. Prod recall (Z-0298-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm recall (Z-0299-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot #: recall (Z-0300-2011)Ethicon Endo-Surgery Inc2010-11-02
REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJ recall (Z-0301-2011)Ethicon Endo-Surgery Inc2010-11-02
SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and App recall (Z-0302-2011)Ethicon Endo-Surgery Inc2010-11-02
SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier Product recall (Z-0303-2011)Ethicon Endo-Surgery Inc2010-11-02
Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 1116051 recall (Z-0304-2011)Ethicon Endo-Surgery Inc2010-11-02
Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05 recall (Z-2635-2010)Ethicon Endo-Surgery Inc2010-09-30
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe (Product Code recall (Z-0655-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Co recall (Z-0656-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe (Produc recall (Z-0657-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe (P recall (Z-0658-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe (Product Code recall (Z-0659-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe (Product Co recall (Z-0660-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe (Produc recall (Z-0661-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe (P recall (Z-0662-2009)Ethicon Endo-Surgery Inc2009-01-27
Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe (Product Cod recall (Z-0663-2009)Ethicon Endo-Surgery Inc2009-01-27
ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, uro recall (Z-2161-2008)Ethicon Endo-Surgery Inc2008-08-25
ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologi recall (Z-2162-2008)Ethicon Endo-Surgery Inc2008-08-25
ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, recall (Z-2163-2008)Ethicon Endo-Surgery Inc2008-08-25
FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58 recall (Z-2164-2008)Ethicon Endo-Surgery Inc2008-08-25
Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon recall (Z-0565-2008)Ethicon Endo-Surgery Inc2008-01-29
Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains: 1 recall (Z-0980-2007)Ethicon Endo-Surgery Inc2007-06-28
Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length, hollow tip electrdode, P recall (Z-0915-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01. recall (Z-0916-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02. recall (Z-0917-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04. recall (Z-0918-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip electrode, recall (Z-0919-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip electro recall (Z-0920-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow tip el recall (Z-0921-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip electrode, C recall (Z-0922-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length, hollow tip ele recall (Z-0923-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip electrode, Co recall (Z-0924-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm length, Code recall (Z-0925-06)Ethicon Endo-Surgery Inc2006-05-31
Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13. recall (Z-0926-06)Ethicon Endo-Surgery Inc2006-05-31

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Every clearance here is in the API, with alerts when new ones post.