The Recall Desk

Manufacturer

Smith & Nephew, Inc. Endoscopy Division

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

What the numbers show

Total
37
Critical
0
Severe
4
Most recent
2014-07-23

Of the 37 recalls from Smith & Nephew, Inc. Endoscopy Division we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (11%) 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.

1–25 of 37

  • SevereFDA (Devices)·Z-2046-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach

    Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.

    Product
    SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach

    Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach

    Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.

    Product
    TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier. The recall covers 10,296 units distributed worldwide.

    Product
    OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 5.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2013·2013-09-25

    Smith & Nephew Recalls BIORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling BIORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX ULTRA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2013·2013-09-25

    Smith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2225-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2013·2013-09-25

    Smith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide