The Recall Desk

Hazard

Sterility Compromise recalls

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

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.

301–325 of 328

  • HighFDA (Devices)·Z-0410-2022·2021-12-29

    Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.

    Product
    Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0407-2022·2021-12-29

    Cataract Surgery Kits Recalled for Compromised Sterile Packaging

    Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.

    Product
    Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0406-2022·2021-12-29

    Surgical Corneal Kit Packaging May Compromise Product Sterility

    Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.

    Product
    Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0408-2022·2021-12-29

    Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk

    Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.

    Product
    Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0368-2022·2021-12-22

    SmartGown Breathable Surgical Gowns recalled for packaging seal defects

    Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.

    Product
    SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

    Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2022·2021-12-22

    Surgical Gowns Recalled Due to Potential Packaging Seal Defects

    Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2022·2021-12-22

    Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect

    Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2022·2021-11-03

    BD Syringe Tip Cap Packaging Defect May Compromise Sterility

    Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.

    Product
    BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0021-2022·2021-10-13

    OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier

    Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.

    Product
    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2021·2021-09-29

    Biopsy Needle Recall Due to Compromised Sterility Assurance

    M.D.L. S.r.l. is recalling 2,750 Aspirated Cyto-Histological Biopsy needles nationwide due to compromised sterility assurance. Affected healthcare providers and patients should consult their healthcare provider for guidance.

    Product
    Aspirated Cyto-Histological Biopsy needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2021·2021-09-29

    Bone Marrow Biopsy Needles Recalled for Sterility Assurance Concerns

    M.D.L. S.r.l. is recalling approximately 21,518 bone marrow biopsy needles distributed nationwide because sterility assurance may be compromised.

    Product
    Bone Marrow Transplantation biopsy needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2021·2021-09-29

    General Manual Surgical Instruments Recalled Due to Compromised Sterility Assurance

    M.D.L. S.r.l. is recalling approximately 4,120 units of general manual surgical instruments nationwide due to compromised sterility assurance. Healthcare facilities should verify lot numbers and quarantine affected instruments immediately.

    Product
    General Manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2021·2021-09-08

    Discectomy Device Kit Class II recall due to sterile barrier compromise

    Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.

    Product
    Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2234-2021·2021-08-18

    Medline Arthroscopy Kit Recalled for Expired Irrigation Component

    Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.

    Product
    Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2021·2021-07-28

    Hemodialysis concentrate recalled for freezing exposure during transport

    Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.

    Product
    (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunct
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2090-2021·2021-07-28

    Fresenius Sterile Stay Safe Cap Recalled for Freezing Temperature Exposure

    Fresenius recalls 39 cases of Sterile Stay Safe Caps (lot numbers B1ZH191, B1ZI092) distributed to Texas due to exposure to freezing temperatures during refrigerated truck malfunction, which may have compromised product sterility.

    Product
    050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the s
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2089-2021·2021-07-28

    MTS Set dialysis accessory recalled for freezing temperature exposure during transport

    Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.

    Product
    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in
    Category
    Medical Device
    Distribution
    1 state