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Ethicon, Inc. FDA Recalls
16 recalls on file across devices, 0 of them Class I and 15 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxiClass IIOct 8, 2024Due a component mix-up in manufacturing, the affected produc |
| Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358HClass IISep 25, 2024Complaints were received regarding needle pull-off and sutur |
| VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligatClass IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absClass IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or liClass IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use Class IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in Class IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiClass IIMay 10, 2024Issue on a specific packaging machine resulted in a hole in |
| SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.Class IIApr 23, 2024Some applicator tips from these lots had open seals. |
| STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IClass IIMar 8, 2024Degraded and unusable upon removal from the foil pouch due t |
| PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use inClass IIMar 31, 2023Suture breakage during intra-operative use could result in p |
| PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approxClass IINov 16, 2022knot tensile strengths were observed to be significantly bel |
| STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of Class IISep 20, 2022Packages may contain a PS-1 cutting edge needle and not the |
| PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release NeedlesClass IIAug 8, 2022Product may contain the incorrect material which could impac |
| 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 PClass IIMar 24, 2022Affected product lots may contain the incorrect needle type/ |
| Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of Class IIJan 4, 2021Product distributed with a red tape as part of the sterile p |