The Recall Desk

Manufacturer

Smith & Nephew, Inc.

258 recalls in our database name Smith & Nephew, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
258
Critical
0
Severe
23
Most recent
2026-06-24

Of the 258 recalls from Smith & Nephew, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 23 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

226–250 of 258

  • HighFDA (Devices)·Z-0589-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformed Inlet Ports

    Smith & Nephew is recalling RENASYS EZ and EZ Plus 800 mL canisters with deformed inlet ports on the lid. The defect may affect the collection of wound exudate during negative pressure wound therapy.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

    Product
    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2688-2014·2014-10-01

    Smith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems

    Smith & Nephew is recalling RENASYS EZ Negative Pressure Wound Therapy Systems because modifications were made without required FDA notifications.

    Product
    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2014·2014-08-27

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

    Product
    TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2014·2014-05-28

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 Trigen Intertan Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1637-2014·2014-05-28

    Smith & Nephew Recalls Trigen Intertan 1.5 Nails Due to Manufacturing Error

    Smith & Nephew is recalling 1,253 units of Trigen Intertan 1.5 Nails because a manufacturing error caused set screws to be inserted too deep.

    Product
    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Ortho
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1161-2014·2014-03-19

    Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2014·2014-03-19

    Smith & Nephew RENASYS-F Foam Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-F Foam Dressing Kits with Soft Port due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1159-2014·2014-03-19

    Smith & Nephew RENASYS-F XL Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2014·2014-03-19

    Smith & Nephew RENASYS-AB Abdominal Dressing Kit Recall for Sealing Defects

    Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2014·2014-03-19

    Smith & Nephew RENASYS Soft Port Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS Soft Port Dressing Kits because inadequate sealing may prevent wound fluid evacuation and fail to trigger pump alarms.

    Product
    Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2014·2014-03-19

    Smith & Nephew Recalls RENASYS Gauze with Soft Port Kits

    Smith & Nephew is recalling RENASYS Gauze with Soft Port Kits because inadequate sealing can cause fluid to remain under the dressing and prevent the pump alarm from activating.

    Product
    Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2014·2014-03-05

    Smith & Nephew Recalls Reflection Interfit Shell Due to Undersized Radius

    Smith & Nephew is recalling 10 units of Reflection Interfit Shells because the inner spherical radius is undersized. The affected devices were distributed in the US and internationally.

    Product
    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1068-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ PLUS Canisters for Labeling Changes

    Smith & Nephew is recalling Renasys EZ PLUS canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ Canisters for Labeling and Filter Changes

    Smith & Nephew is recalling Renasys EZ canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2014·2014-01-01

    Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues

    Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.

    Product
    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0449-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 8 units of Genesis II mobile bearing articular inserts because the Tyvek lid may not be adequately sealed.

    Product
    GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0446-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0448-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0444-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 16 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0445-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 45 units of Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0447-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Sealing Defect

    Smith & Nephew is recalling 32 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0130-2014·2013-11-13

    Smith & Nephew Recalls Mispackaged Genesis II Tibial Base Components

    Smith & Nephew is recalling four units of Genesis II tibial base components due to size and side mislabeling.

    Product
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Smith & Nephew

a company producing medical equipment

Country
United Kingdom
Founded
1856

Official website

Source: Wikidata (Q502509), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.