The Recall Desk

Hazard

Sterility Breach recalls

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

What the numbers show

Total
462
Critical
0
Severe
21
Most recent
2026-07-22

Of the 462 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 21 (5%) 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 462

  • 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-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-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-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-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-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-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
  • 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-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-2460-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 860 units of Sterile Standalone Connectors because internal tests identified a potential breach in the sterile barrier.

    Product
    3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2448-2020·2020-07-08

    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 S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
    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-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-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
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    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 STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2452-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2457-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2449-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
    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-2329-2020·2020-06-17

    Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk

    Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2020·2020-06-17

    Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk

    Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide