Browse Device Recalls

70 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 70 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 70 FDA device recalls.

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Date	Product	Reason	Class	Firm
Oct 8, 2024	MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indic...	Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/...	Class II	ETHICON, INC.
Sep 25, 2024	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc...	Complaints were received regarding needle pull-off and suture degradation. Analysis on returned p...	Class II	Ethicon, Inc.
May 10, 2024	MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in ...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
May 10, 2024	VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in gen...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
May 10, 2024	PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
May 10, 2024	VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue ap...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
May 10, 2024	MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
May 10, 2024	PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s...	Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril...	Class II	Ethicon, Inc.
Apr 23, 2024	SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.	Some applicator tips from these lots had open seals.	Class II	Ethicon, Inc.
Mar 8, 2024	STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: ...	Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions du...	Class II	Ethicon, Inc.
Mar 31, 2023	PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3...	Suture breakage during intra-operative use could result in poor performance of the impacted produ...	Class II	Ethicon, Inc.
Nov 16, 2022	PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product C...	knot tensile strengths were observed to be significantly below the minimum knot tensile, will res...	Class II	Ethicon, Inc.
Sep 20, 2022	STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ...	Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may re...	Class II	Ethicon, Inc.
Aug 8, 2022	PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, ...	Product may contain the incorrect material which could impact treatment.	Class II	Ethicon, Inc.
Mar 24, 2022	STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product cod...	Affected product lots may contain the incorrect needle type/size and suture length due to compone...	Class II	Ethicon, Inc.
Jan 4, 2021	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol...	Product distributed with a red tape as part of the sterile packaging which could impact the seal ...	Class II	Ethicon, Inc.
Oct 23, 2020	PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm	The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a cus...	Class II	Ethicon, Inc.
Sep 9, 2020	VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ...	Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. T...	Class II	Ethicon, Inc.
Jun 10, 2020	PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7...	Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years	Class II	Ethicon, Inc.
Jan 3, 2020	Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The de...	Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced t...	Class II	Ethicon, Inc.
Aug 28, 2019	1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 28, 2019	1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 28, 2019	1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201	The product do not meet certain internal testing specifications.	Class II	Ethicon, Inc.
Aug 13, 2019	STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B...	The product does not meet certain internal strength testing specifications.	Class II	Ethicon, Inc.
Aug 13, 2019	STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B4...	The product does not meet certain internal strength testing specifications.	Class II	Ethicon, Inc.
Apr 19, 2019	ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Pr...	Possibility that a suture raw material containing high endotoxin levels was used in the manufact...	Class II	Ethicon, Inc.
Apr 19, 2019	ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 ...	Possibility that a suture raw material containing high endotoxin levels was used in the manufact...	Class II	Ethicon, Inc.
Mar 12, 2019	VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN...	VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ...	Class II	Ethicon, Inc.
Mar 12, 2019	VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTU...	VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ...	Class II	Ethicon, Inc.
Mar 12, 2019	PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende...	VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ...	Class II	Ethicon, Inc.
Dec 18, 2018	PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Pr...	The sutures inside the packaging are not the same size or type as indicated on the label.	Class II	Ethicon, Inc.
Jun 8, 2018	PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18...	Products do not meet a tensile strength specification	Class II	Ethicon, Inc.
Jun 8, 2018	PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single...	Products do not meet a tensile strength specification	Class II	Ethicon, Inc.
Jun 8, 2018	PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Ar...	Products do not meet a tensile strength specification	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PRONOVA SUTURE BLUE 122CM M1.5, D10189	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.
May 7, 2018	PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067	The needle associated with certain suture product codes has the potential to perforate the packag...	Class II	Ethicon, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.