Recall archive
36 recalls · page 1 of 2
Reported Nov 27, 2024
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures…
FDA (openFDA device enforcement)
Reported Jun 26, 2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Some applicator tips from these lots had open seals.
FDA (openFDA device enforcement)
Reported Apr 24, 2024
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
FDA (openFDA device enforcement)
Reported May 17, 2023
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue…
FDA (openFDA device enforcement)
Reported Dec 21, 2022
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively…
FDA (openFDA device enforcement)
Reported Nov 9, 2022
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for…
FDA (openFDA device enforcement)
Reported Sep 28, 2022
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Product may contain the incorrect material which could impact treatment.
FDA (openFDA device enforcement)
Reported May 18, 2022
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
FDA (openFDA device enforcement)
Reported Feb 10, 2021
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand · Product · Product details — Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
FDA (openFDA device enforcement)
Reported Dec 9, 2020
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging…
FDA (openFDA device enforcement)
Reported Oct 28, 2020
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10…
FDA (openFDA device enforcement)
Reported Jul 8, 2020
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
FDA (openFDA device enforcement)
Reported Feb 26, 2020
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — The product do not meet certain internal testing specifications.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
FDA (openFDA device enforcement)
Reported Oct 16, 2019
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — The product does not meet certain internal strength testing specifications.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2019
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 23, 2019
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND*…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — The sutures inside the packaging are not the same size or type as indicated on the label.
FDA (openFDA device enforcement)
Reported Aug 1, 2018
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Products do not meet a tensile strength specification
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2018
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated…
18 more products in this recall
FDA (openFDA device enforcement)
Reported May 2, 2018
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Products labeled for distribution outside the United States may have been distributed to customers in the United States.
FDA (openFDA device enforcement)
Reported Apr 18, 2018
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
Matched: Brand — Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of…
2 more products in this recall
FDA (openFDA device enforcement)
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