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.

151–175 of 2228

  • HighFDA (Devices)·Z-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2024·2024-08-14

    American Contract Systems surgical kits recalled for sterilization defect

    American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.

    Product
    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2024·2024-07-31

    BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution

    Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.

    Product
    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2024·2024-07-17

    Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks

    Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2024·2024-07-10

    Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices

    Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.

    Product
    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2024·2024-06-26

    Ethicon MONOCRYL Plus Sutures Recalled for Packaging Defect

    Ethicon recalled 287,892 MONOCRYL Plus Antibacterial Sutures worldwide due to a packaging machine defect that created holes in primary packaging, potentially compromising sterility and risking infection.

    Product
    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2024·2024-06-26

    PDS II Polydioxanone Sutures Recalled Due to Compromised Sterility

    Ethicon is recalling 56,952 units of PDS II polydioxanone sutures distributed worldwide because a packaging defect resulted in compromised sterility, which could lead to infection. No illnesses have been reported.

    Product
    PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2024·2024-06-26

    PDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility

    Ethicon recalls PDS Plus Antibacterial sutures due to packaging defects that compromised sterility. The affected units may cause infection if used in surgery.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2024·2024-06-26

    MONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect

    Ethicon recalls 306,000 MONOCRYL surgical sutures worldwide due to holes in primary packaging from a manufacturing defect that compromises sterility and could result in infection.

    Product
    MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2024·2024-06-26

    VICRYL Sutures recalled due to packaging defect compromising sterility

    Ethicon recalls 341,532 units of VICRYL surgical sutures worldwide due to holes in primary packaging that compromise sterility and could result in infection.

    Product
    VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2024·2024-06-26

    FDA Recalls VICRYL Plus Antibacterial Sutures Due to Packaging Defect

    Ethicon is recalling VICRYL Plus Antibacterial Sutures due to a packaging machine defect that created holes in the primary packaging, potentially compromising product sterility. Affected sutures may pose an infection risk.

    Product
    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB94
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2024·2024-06-19

    CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall

    Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.

    Product
    CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2024·2024-06-19

    CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled

    Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.

    Product
    CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2024·2024-05-29

    Integra Cranial Access Kit Packaging Defects May Compromise Sterility

    Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.

    Product
    Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2024·2024-05-22

    CoFlex NL Sterile Bandages Recalled for Packaging Seal Gaps

    Andover Healthcare Inc. is recalling CoFlex NL sterile flexible cohesive bandages (model 5400S) due to packaging seal gaps that could compromise product sterility. No illnesses have been reported.

    Product
    Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2024·2024-04-24

    Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects

    Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.

    Product
    Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2024·2024-04-24

    Trocar Needle Recall Due to Packaging Seal Strength Defect

    Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.

    Product
    Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2024·2024-04-24

    Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

    Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

    Product
    Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2024·2024-04-24

    Peel-Away Introducer medical devices recalled for low packaging seal strength

    Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.

    Product
    Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2024·2024-04-24

    Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect

    Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.

    Product
    Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2024·2024-04-24

    Surgical Sutures Recalled for Sterility Compromise During Transit

    Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.

    Product
    STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1525-2024·2024-04-24

    Chiba Biopsy Needles Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.

    Product
    Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2024·2024-04-24

    Cook Coons Taper Dilators recalled due to low packaging seal strength

    Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

    Product
    Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
    Category
    Medical Device
    Distribution
    Distributed nationwide