The Recall Desk

Hazard

Sterility Breach recalls

473 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
473
Critical
0
Severe
27
Most recent
2026-09-23

Of the 473 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility breach recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

251–275 of 473

  • HighFDA (Devices)·Z-0137-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 5.0mm AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0146-2021·2020-10-28

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Packaging Seal Issues

    Smith & Nephew is recalling Bioraptor 2.9mm Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2021·2020-10-28

    Smith & Nephew Recalls Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling HEALICOIL RSB SA absorbable suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2021·2020-10-28

    Smith & Nephew Recalls Healicoil Absorbable Suture Anchors for Seal Defects

    Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0141-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX AB 5.0 Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0160-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0151-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0148-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR 2.3 W 1UB II BLUE absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2020·2020-07-08

    LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2453-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2456-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2443-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 120 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2450-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2447-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2445-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
    Category
    Medical Device
    Distribution
    44 states