Somerville, NJ, United States
Ethicon, Inc. recalls
30 recalls recorded since 2018, most recently on 8 September 2026. 15 are listed as ongoing. Status and classification are as published by the FDA.
Recalls30
Ongoing (FDA)15
Terminated or completed15
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 September 2026
- Reason
- Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
- Distribution
- Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0153-2027
- PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Ongoing Class II Medical devices
- Recall started
- 15 August 2025
- Reason
- Potential for barb non-engagement.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2605-2025
- STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
Ongoing Class II Medical devices
- Recall started
- 20 December 2024
- Reason
- Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1096-2025, Z-1098-2025, Z-1097-2025
- PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgi
- ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
- PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical proc
Ongoing Class II Medical devices
- Recall started
- 8 October 2024
- Reason
- Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0487-2025
- MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or
Ongoing Class II Medical devices
- Recall started
- 25 September 2024
- Reason
- Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- Distribution
- International distribution to the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0319-2025
- Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Distribution
- Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2147-2024, Z-2148-2024, Z-2144-2024, Z-2146-2024, Z-2145-2024, Z-2149-2024
- PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are parti
- MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y
- VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE:
- PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful w
- VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VC
- MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H1
Ongoing Class II Medical devices
- Recall started
- 23 April 2024
- Reason
- Some applicator tips from these lots had open seals.
- Distribution
- US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1881-2024
- SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Ongoing Class II Medical devices
- Recall started
- 8 March 2024
- Reason
- Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- Distribution
- CO GA IA MI NJ NY NY PA SC WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1533-2024
- STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of a
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2616-2023, Z-2617-2023
- PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP
- PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z
Ongoing Class II Medical devices
- Recall started
- 31 March 2023
- Reason
- Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
- Distribution
- International distribution in the countries of United Kingdom, Ireland and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1571-2023
- PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code:
Ongoing Class II Medical devices
- Recall started
- 16 November 2022
- Reason
- knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
- Distribution
- International (OUS) only: Canada, Japan, Australia and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0480-2023
- PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opht
Ongoing Class II Medical devices
- Recall started
- 20 September 2022
- Reason
- 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 taper point needles, which may necessitate repair
- Distribution
- International distribution of the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0150-2023
- STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Ongoing Class II Medical devices
- Recall started
- 8 August 2022
- Reason
- Product may contain the incorrect material which could impact treatment.
- Distribution
- Distribution in Japan only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1773-2022
- PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Ongoing Class II Medical devices
- Recall started
- 24 March 2022
- Reason
- Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
- Distribution
- International distribution in the country of China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1053-2022
- 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 PS-1, product code: SXMD1B100-12].
Terminated Class II Medical devices
- Recall started
- 4 January 2021
- Terminated
- 29 November 2023
- Reason
- Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0953-2021
- Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 21 December 2022
- Reason
- 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 of a single unit.
- Distribution
- The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0533-2021
- PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Terminated Class II Medical devices
- Recall started
- 9 September 2020
- Terminated
- 7 November 2023
- Reason
- 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 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
- Distribution
- International distribution including the countries of Australia, Canada, Japan, and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0116-2021
- VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Ongoing Class II Medical devices
- Recall started
- 10 June 2020
- Reason
- Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
- Distribution
- No domestic distribution. Foreign distribution to Algeria Angola Australia Austria Azerbaijan Bahrain Belgium Bosnia and Herzegovina Canada Chad Chile Czechia Egypt Finland France Gabon Germany Greece Hong Kong Iceland India Iran Ireland Israel Italy Japan Jordan Kenya Ku
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2486-2020
- PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 13 August 2021
- Reason
- Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
- Distribution
- Domestic distribution nationwide. US and Puerto Rico only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0989-2020
- Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Terminated Class II Medical devices
- Recall started
- 28 August 2019
- Terminated
- 11 February 2021
- Reason
- The product do not meet certain internal testing specifications.
- Distribution
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1334-2020, Z-1335-2020, Z-1336-2020
- 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
- 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
- 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
Terminated Class II Medical devices
- Recall started
- 13 August 2019
- Terminated
- 11 February 2021
- Reason
- The product does not meet certain internal strength testing specifications.
- Distribution
- States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0048-2020, Z-0047-2020
- STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
- STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Terminated Class II Medical devices
- Recall started
- 19 April 2019
- Terminated
- 5 February 2021
- Reason
- Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Distribution
- Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1841-2019, Z-1842-2019
- ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, includi
- ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including
Terminated Class II Medical devices
- Recall started
- 12 March 2019
- Terminated
- 17 July 2020
- Reason
- VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
- Distribution
- Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1136-2019, Z-1135-2019, Z-1134-2019
- PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surge
- VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SUTURE 18"(45CM) 1 VIO VICRYL PLUS
- VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL
Terminated Class II Medical devices
- Recall started
- 18 December 2018
- Terminated
- 29 May 2020
- Reason
- The sutures inside the packaging are not the same size or type as indicated on the label.
- Distribution
- The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0747-2019
- PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use i
Terminated Class II Medical devices
- Recall started
- 8 June 2018
- Terminated
- 25 September 2020
- Reason
- Products do not meet a tensile strength specification
- Distribution
- Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2533-2018, Z-2534-2018, Z-2532-2018
- PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
- PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
- PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
Terminated Class II Medical devices
- Recall started
- 7 May 2018
- Terminated
- 8 June 2020
- Reason
- The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
- Distribution
- Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2448-2018, Z-2464-2018, Z-2465-2018, Z-2459-2018, Z-2455-2018, Z-2458-2018, Z-2463-2018, Z-2453-2018, Z-2450-2018, Z-2451-2018, Z-2462-2018, Z-2457-2018 and 7 more
- PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
- PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
- PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
- PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
- PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
- PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
- PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
- PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
- and 11 more product lines
Terminated Class II Medical devices
- Recall started
- 7 March 2018
- Terminated
- 30 April 2019
- Reason
- Products labeled for distribution outside the United States may have been distributed to customers in the United States.
- Distribution
- The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1534-2018
- Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Terminated Class II Medical devices
- Recall started
- 10 January 2018
- Terminated
- 11 April 2019
- Reason
- 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 manufacture instead of the correct expiry date of two (2) years from date of manufacture.
- Distribution
- Distribution US Nationwide, Canada, India, and Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1338-2018, Z-1340-2018, Z-1339-2018
- PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
- PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
- PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Terminated Class II Medical devices
- Recall started
- 27 November 2017
- Terminated
- 30 April 2019
- Reason
- Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1147-2018
- DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punc
Terminated Class II Medical devices
- Recall started
- 17 August 2017
- Terminated
- 8 May 2019
- Reason
- On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2018
- Coated VICRYL RAPIDETM (Polyglactin 910) Suture
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.