The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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.

1–25 of 2235

  • ModerateFDA (Devices)·Z-3261-2026·2026-09-30

    AVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues

    AVID Medical is recalling 192 Halyard IV Start Kits because the included BD ChloraPrep applicators may have open or incomplete packaging seals.

    Product
    Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3207-2026·2026-09-23

    Medline Anesthesia Pain Kits Recalled for Potential Sterility Compromise

    Medline Industries is recalling 341 anesthesia pain kits due to open sterile seals that may compromise sterility and lead to patient infection.

    Product
    Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3146-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity, posing a risk of infection.

    Product
    Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2026·2026-09-23

    Medline Myringotomy Kits Recalled for Potential Sterility Compromise

    Medline Industries is recalling 60 Myringotomy Pack-LF kits due to open seals that may compromise sterility and lead to patient infection.

    Product
    Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3210-2026·2026-09-23

    Medline Recalls Cataract Convenience Kits Due to Open Sterile Seals

    Medline Industries is recalling 336 cataract convenience kits because open sterile seals may compromise sterility and lead to patient infection.

    Product
    Convenience kits CATARACT PACK DYNJ59881A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3107-2026·2026-09-16

    Medical Action Industries Recalls Single Shot Epidural Kits Due to Sterility Concerns

    Medical Action Industries is recalling Single Shot Epidural kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945B. Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-3106-2026·2026-09-16

    Medical Action Industries Recalls Epidural Kits Due to Compromised Sterility

    Medical Action Industries is recalling Epidural/Pain TQC kits containing Sodium Chloride ampules due to potentially compromised sterility.

    Product
    Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP 10ml ampules
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2873-2026·2026-08-19

    Spectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns

    Spectra Medical Devices is recalling Sodium Chloride Injection ampules because manufacturing issues may have compromised sterility, posing a risk of infection or inflammation to patients.

    Product
    Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2864-2026·2026-08-12

    Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece

    Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.

    Product
    STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage

    Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2869-2026·2026-08-12

    Intramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage

    Biomet, Inc. is recalling various sizes of Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2871-2026·2026-08-12

    Intramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage

    Biomet, Inc. is recalling certain Intramedullary Bone Saw Blade Assemblies because an exposed saw blade may have damaged the sterile barrier packaging.

    Product
    Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2794-2026·2026-07-29

    Flexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals

    Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seals, which could compromise sterility assurance during gynecological procedures.

    Product
    Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2026·2026-07-08

    DePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall

    DePuy Synthes is recalling ATTUNE Revision Hinge Knee Insert Components distributed to Minnesota, North Carolina, and Texas because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2616-2026·2026-07-08

    DePuy Synthes ATTUNE Revision Hinge Knee Components Packaging Sterility Issue

    DePuy Synthes is recalling ATTUNE Revision Hinge Knee Housing Components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility. The recall affects 66 units distributed to Minnesota, North Carolina, and Texas.

    Product
    Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2614-2026·2026-07-08

    Mentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error

    Mentor Texas LP is recalling a single lot of expired 10cc Luer Lok syringes distributed to California, Florida, and Pennsylvania due to a distribution system control failure.

    Product
    SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2186-2026·2026-05-20

    Reprocessed Electrophysiology Catheters Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.

    Product
    Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2192-2026·2026-05-20

    Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled

    Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.

    Product
    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.

    Product
    BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2026·2026-05-20

    Daig Livewire Steerable BDB Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.

    Product
    Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals

    Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.

    Product
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.

    Product
    BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.

    Product
    BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide