The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise 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.

1626–1650 of 2228

  • ModerateFDA (Devices)·Z-0880-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.

    Product
    Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0732-2016·2016-02-10

    JosNoe PS-500 Scope Warmer Recalled for Package Seal Damage

    JosNoe Medical is recalling PS-500 Scope Warmers because damaged package seals may compromise sterility. The recall covers 1,008 boxes distributed in the US and Canada.

    Product
    PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2016·2016-01-27

    Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise

    Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2016·2016-01-27

    Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise

    Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2016·2016-01-27

    Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise

    Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 embolectomy catheters worldwide due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0387-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2016·2015-12-16

    LeMaitre NovaSil Silicone Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2016·2015-12-16

    LeMaitre NovaSil Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2016·2015-12-09

    DeRoyal and GEO-MED sterile surgical kits recalled for seal defects

    DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.

    Product
    DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0362-2016·2015-12-09

    Stryker Duracon Tibial Wedge Implants Recalled for Packaging Integrity Issues

    Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.

    Product
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2016·2015-11-25

    US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 33,778 vials of Triamcinolone diacetate USP PF (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0278-2016·2015-11-25

    Ethicon Harmonic ACE+ 7 Laparoscopic Shears Recalled for Packaging Defect

    Ethicon Endo-Surgery is recalling Harmonic ACE+ 7 Laparoscopic Shears because holes in the Tyvek packaging can compromise the sterile barrier.

    Product
    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2016·2015-11-18

    Medtronic Recalls Amphirion Deep PTA Balloon Catheters Due to Seal Breach

    Medtronic is recalling Amphirion Deep PTA Balloon Catheters because a potential breach in the pouch seal may compromise the sterilized product.

    Product
    Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2016·2015-11-18

    Utah Medical Recalls Myelo-Nate CSF Sampling Kits Due to Seal Compromise

    Utah Medical Products is recalling 21,403 Myelo-Nate CSF Sampling Kits because an internal inspection found a compromised sterile seal on one side of the tray.

    Product
    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0191-2016·2015-11-04

    Resource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.

    Product
    Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states