Ethicon, Inc.: 70 FDA recall reports
Every medical device recall the FDA has published for Ethicon, Inc.. The fault, and how the agency graded it.
70Reports
2Class I
17Ongoing
2024-11-27Most recent
2 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tiss
Z-0487-2025 · Class II · reported 2024-11-27 · Ongoing
- Why it was recalled
- Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- Product
- 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 ophthalmic surgery.
- Where it went
- 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.
- How much
- 16,524 devices
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Z-0319-2025 · Class II · reported 2024-11-13 · Ongoing
- Why it was recalled
- 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.
- Product
- Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Where it went
- International distribution to the country of China.
- How much
- 31,032 units
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, includi
Z-2147-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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 particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
- Where it went
- 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.
- How much
- 45828 units
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation wh
Z-2148-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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 Y417H Y426H Y427H Y935H Y936H Y945H
- Where it went
- 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.
- How much
- 306000 units
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, incl
Z-2144-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
- Where it went
- 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.
- How much
- 341532 units
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paedia
Z-2146-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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 where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
- Where it went
- 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.
- How much
- 56952 units
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation an
Z-2145-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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 VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
- Where it went
- 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.
- How much
- 55296 units
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation
Z-2149-2024 · Class II · reported 2024-06-26 · Ongoing
- Why it was recalled
- Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Product
- 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 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
- Where it went
- 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.
- How much
- 287892 units
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Z-1881-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- Some applicator tips from these lots had open seals.
- Product
- SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
- Where it went
- 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.
- How much
- 5,184 units
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI
Z-1533-2024 · Class II · reported 2024-04-24 · Ongoing
- Why it was recalled
- Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- Product
- 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 absorbable sutures is appropriate. Product Code: SXMP2B412
- Where it went
- CO GA IA MI NJ NY NY PA SC WI
- How much
- 395 units
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended
Z-1571-2023 · Class II · reported 2023-05-17 · Ongoing
- Why it was recalled
- 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
- Product
- 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: PDP9625H
- Where it went
- International distribution in the countries of United Kingdom, Ireland and Turkey.
- How much
- 1,656 eaches (OUS only)
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tis
Z-0480-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- 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
- Product
- 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 ophthalmic surgery
- Where it went
- International (OUS) only: Canada, Japan, Australia and New Zealand
- How much
- 7,560 eaches
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where t
Z-0150-2023 · Class II · reported 2022-11-09 · Ongoing
- Why it was recalled
- 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
- Product
- 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
- Where it went
- International distribution of the country of China.
- How much
- 2,280 eaches
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Releas
Z-1773-2022 · Class II · reported 2022-09-28 · Ongoing
- Why it was recalled
- Product may contain the incorrect material which could impact treatment.
- Product
- PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Where it went
- Distribution in Japan only
- How much
- 88 boxes (1056 ea)
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0
Z-1053-2022 · Class II · reported 2022-05-18 · Ongoing
- Why it was recalled
- Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
- Product
- 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].
- Where it went
- International distribution in the country of China.
- How much
- 2808 (all OUS)
Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin
Z-0953-2021 · Class II · reported 2021-02-10 · Terminated
- Why it was recalled
- Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
- Product
- 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
- Where it went
- US Nationwide
- How much
- 23,580 eaches
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Z-0533-2021 · Class II · reported 2020-12-09 · Terminated
- Why it was recalled
- 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.
- Product
- PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
- Where it went
- 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.
- How much
- 295 units distributed. Only 15 units are being recalled.
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophth
Z-0116-2021 · Class II · reported 2020-10-28 · Terminated
- Why it was recalled
- 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
- Product
- 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
- Where it went
- International distribution including the countries of Australia, Canada, Japan, and New Zealand
- How much
- 1,032 eaches (OUS only)
PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058
Z-2486-2020 · Class II · reported 2020-07-08 · Ongoing
- Why it was recalled
- Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
- Product
- 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
- Where it went
- 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 Kuwait Latvia Lebanon Libya Lithuania Mauritius Morocco Mozambique Netherlands (the) New Caledonia New Zealand Nigeria Oman Philippines Poland Portugal Qatar Republic of North Macedonia Russian Federation (the) Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates (the) United Kingdom of Great Britain and Northern Ireland (the)
- How much
- 99,612 eaches
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Z-1334-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- The product do not meet certain internal testing specifications.
- Product
- 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
- Where it went
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
- How much
- 3 units
1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
Z-1335-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- The product do not meet certain internal testing specifications.
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
- Where it went
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
- How much
- 660 units
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
Z-1336-2020 · Class II · reported 2020-02-26 · Terminated
- Why it was recalled
- The product do not meet certain internal testing specifications.
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
- Where it went
- International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
- How much
- 133 units
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable st
Z-0989-2020 · Class II · reported 2020-02-12 · Terminated
- Why it was recalled
- Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
- Product
- Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
- Where it went
- Domestic distribution nationwide. US and Puerto Rico only.
- How much
- 23688 units
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Z-0048-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- The product does not meet certain internal strength testing specifications.
- Product
- STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
- Where it went
- 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
- How much
- 852 each
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
Z-0047-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- The product does not meet certain internal strength testing specifications.
- Product
- STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
- Where it went
- 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
- How much
- 416 each
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Us
Z-1841-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Product
- 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, including use in cardiovascular, ophthalmic and neurological procedures
- Where it went
- Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
- How much
- 1296 eaches
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usag
Z-1842-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot
- Product
- 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 use in cardiovascular, ophthalmic and neurological procedures
- Where it went
- Worldwide - US Nationwide Distribution - IA, NJ, RI, TX, WV Foreign: Canada
- How much
- 36 eaches
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approxim
Z-1136-2019 · Class II · reported 2019-04-24 · Terminated
- Why it was recalled
- VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
- Product
- 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 surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
- Where it went
- Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
- How much
- 550,681 eaches (WW) Total
VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS S
Z-1135-2019 · Class II · reported 2019-04-24 · Terminated
- Why it was recalled
- VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
- Product
- 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 SUTURE 18"(45CM) 4-0 VIO VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 2-0 UND VICRYL PLUS SUTURE 18"(45CM) 1 UND VICRYL PLUS SUTURE 27"(70CM) 0 UND VICRYL PLUS SUTURE 27"(70CM) 2-0 UND - Product Usage: Coated VICRYL Suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues
- Where it went
- Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
- How much
- 550,681 eaches (WW) Total
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VI
Z-1134-2019 · Class II · reported 2019-04-24 · Terminated
- Why it was recalled
- VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
- Product
- 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 SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
- Where it went
- Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
- How much
- 550,681 eaches (WW) Total
Showing the 30 most recent of 70. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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