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ETHICON, INC.

57 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in recall (Z-0487-2025)ETHICON, INC.2024-11-19
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358 recall (Z-0319-2025)Ethicon, Inc.2024-11-07
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation a recall (Z-2144-2024)Ethicon, Inc.2024-06-14
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tis recall (Z-2145-2024)Ethicon, Inc.2024-06-14
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, inc recall (Z-2146-2024)Ethicon, Inc.2024-06-14
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue ap recall (Z-2147-2024)Ethicon, Inc.2024-06-14
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximatio recall (Z-2148-2024)Ethicon, Inc.2024-06-14
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft recall (Z-2149-2024)Ethicon, Inc.2024-06-14
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. recall (Z-1881-2024)Ethicon, Inc.2024-05-22
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPI recall (Z-1533-2024)Ethicon, Inc.2024-04-12
PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC- recall (Z-1571-2023)Ethicon, Inc.2023-05-10
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For recall (Z-0480-2023)Ethicon, Inc.2022-12-14
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue a recall (Z-0150-2023)Ethicon, Inc.2022-10-31
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 recall (Z-1334-2020)Ethicon, Inc.2020-02-06
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 recall (Z-1335-2020)Ethicon, Inc.2020-02-06
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429 recall (Z-1336-2020)Ethicon, Inc.2020-02-06
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a syn recall (Z-0989-2020)Ethicon, Inc.2020-02-04
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture recall (Z-0047-2020)Ethicon, Inc.2019-10-04
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture recall (Z-0048-2020)Ethicon, Inc.2019-10-04
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Ind recall (Z-1996-2016)Ethicon, Inc.2016-06-15
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMA recall (Z-0602-2016)Ethicon, Inc.2016-01-06
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, recall (Z-1839-2015)Ethicon, Inc.2015-06-25
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made recall (Z-0492-2015)Ethicon, Inc.2015-01-09
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & John recall (Z-1329-2014)Ethicon, Inc.2014-04-03
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, recall (Z-0458-2014)Ethicon, Inc.2013-12-06
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON E recall (Z-0292-2013)Ethicon, Inc.2012-11-16
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 088 recall (Z-0293-2013)Ethicon, Inc.2012-11-16
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blo recall (Z-0111-2013)Ethicon, Inc.2012-10-22
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon recall (Z-1897-2012)Ethicon, Inc.2012-06-27
Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 0887 recall (Z-2756-2011)Ethicon, Inc.2011-07-07
Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-015 recall (Z-2757-2011)Ethicon, Inc.2011-07-07
J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 0887 recall (Z-2758-2011)Ethicon, Inc.2011-07-07
Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 088 recall (Z-2759-2011)Ethicon, Inc.2011-07-07
J-Vac Drain Adaptor Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Cl recall (Z-2760-2011)Ethicon, Inc.2011-07-07
Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc. recall (Z-1496-2011)Ethicon, Inc.2011-03-02
High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx on recall (Z-1497-2011)Ethicon, Inc.2011-03-02
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended f recall (Z-1260-2011)Ethicon, Inc.2011-02-18
PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson recall (Z-0903-2011)Ethicon, Inc.2011-01-14
Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. recall (Z-1608-2010)Ethicon, Inc.2010-05-18
Gynecare Morcellex Tissue Morcellator; Manufactured by: Ethicon Women's Health & Urology; recall (Z-0173-2010)Ethicon, Inc.2009-11-10
Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somervi recall (Z-1309-2009)Ethicon, Inc.2009-05-12
Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johns recall (Z-1310-2009)Ethicon, Inc.2009-05-12
MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somervill recall (Z-1311-2009)Ethicon, Inc.2009-05-12
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson recall (Z-1312-2009)Ethicon, Inc.2009-05-12
PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. recall (Z-1313-2009)Ethicon, Inc.2009-05-12
PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue recall (Z-1314-2009)Ethicon, Inc.2009-05-12
Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets U recall (Z-1315-2009)Ethicon, Inc.2009-05-12
Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramo recall (Z-1316-2009)Ethicon, Inc.2009-05-12
Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each c recall (Z-0992-2009)Ethicon, Inc.2009-03-04
VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-US recall (Z-0021-2009)Ethicon, Inc.2008-10-02
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland recall (Z-0795-2007)Ethicon, Inc.2007-05-10
Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately recall (Z-1101-06)Ethicon, Inc.2006-06-09
Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is recall (Z-1087-06)Ethicon, Inc.2006-06-02
Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), br recall (Z-0907-06)Ethicon, Inc.2006-05-27
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair o recall (Z-0449-06)Ethicon, Inc.2006-01-26
J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is a recall (Z-0076-06)Ethicon, Inc2005-10-21
VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US recall (Z-0493-05)Ethicon, Inc2005-02-02

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