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Smith & Nephew, Inc.

Smith & Nephew, Inc. Recalls

All product recalls associated with Smith & Nephew, Inc..

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Recall Summary

Total Recalls

1000

Past Year

589

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4121–4140 of 10393 recalls

OSTEORAPTOR 2.3 Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

HEALICOIL 5.5MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX ULTRA 4.5 Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Moderate

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Page 207 of 520Next

FDA

Sep 9, 2020

Nationwide

• Smith & Nephew, Inc.

TWINFIX 6.5MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Moderate

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

BIORAPTOR 2.9MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Moderate

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX ULTRA PLLA 5.5MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Moderate

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX 5.0MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Moderate

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

RAPTORMITE 3.7MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

ULTRA FAST-FIX Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX ULTRA 5.5 Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX ULTRA PLLA/HA 6.5 Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

OSTEORAPTOR 2.3 Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

TWINFIX ULTRA PLLA 4.5MM Suture Anchor (Smith & Nephew) - Packaging sterility risk (2020)

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Low

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Class IIILow

FDASep 9, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nuclear Magnetic Resonance Imaging (GE Healthcare) - Electrical arc flash (2020)

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Moderate

FDASep 8, 2020Nationwide• GE Healthcare, LLC

Tomographic Imager (GE Healthcare) - Electrical arc flash (2020)

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Moderate

FDASep 8, 2020Nationwide• GE Healthcare, LLC

Hand Sanitizer (Charles Paint) – Chemical Limit Excess (2020)

CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.

Class IIModerate

FDASep 2, 2020IN, MI• Charles Paint Research Inc

Hand Sanitizer (Charles Paint) – Facility Chemical Risk (2020)

CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.

Class IIModerate

FDASep 2, 2020IN, MI• Charles Paint Research Inc

Boric Acid Vaginal Suppositories (pH-D) – Unapproved Marketing (2020)

Marketed without an Approved NDA/ANDA.

Class IIModerate

FDASep 2, 2020Nationwide• pH-D Feminine Health

Red-E Tablet (Protein Shoppe) – Sildenafil Contamination (2020)

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

Class IHigh

FDASep 1, 2020Nationwide• The Protein Shoppe