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.

251–275 of 2235

  • HighFDA (Devices)·Z-1110-2023·2023-02-22

    Surgical angio port kits recalled for compromised sterile barrier

    Medline is recalling 30 units of surgical angio port kits due to a perforated outer bag that prevents the external packaging from being sterile, creating a contamination risk during surgical use.

    Product
    Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2023·2023-02-15

    Sterile Surgical Trays Recalled for Potential Sterile Packaging Puncture

    Medline Industries recalls sterile surgical procedural trays because blades within the kits could puncture the sterile outer packaging, potentially compromising sterility during surgical use.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2023·2023-02-15

    Sterile Procedural Trays Recalled for Potential Blade Puncture of Packaging

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can potentially puncture the outer foil packaging, compromising sterility. The recall affects approximately 215,456 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard

    Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MAJOR PROCEDURE-LF i. HYPOSPADIUS CDS j. LAPAROSCOPY-GENERAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (Rhinoplasty Pack, OSC Otology Pack-LF, and Rhyzotomy) distributed worldwide because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c. RHYZOTOMY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Packaging Puncture

    Medline Industries is recalling sterile procedural trays because blades within the kits may puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling Sterile Procedural Trays (LS MS PACK) because the sterile blade inside can potentially puncture the outer packaging layer, compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: LS MS PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Package Puncture Risk

    Medline sterile procedural trays are recalled because sterile blades within the kits can puncture the outer foil packaging, potentially compromising sterility. 622 cases (1,619 units) have been distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2023·2023-02-15

    Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk

    Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2023·2023-02-15

    Medline Sterile Procedural Trays Recalled Due to Packaging Puncture Risk

    Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS c. TOTAL ORTHO CDS d. TOTAL KNEE CDS e. CDS HIP-LF f. KNEE TOTAL PACK-LF g. EXTREMITY CDS h. SHOULDER ARTHRO CDS i. GLENNON EXTREMITY CDS j. KNEE ARTHROSCOPY k. TOTAL KNEE l. TOTAL HIP REPLACEMENT m.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2023·2023-02-15

    Medline Sterile Procedural Trays recalled due to packaging defect risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the outer foil sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2023·2023-02-15

    Sterile Surgical Trays Recalled for Blade Puncture Risk

    Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.

    Product
    Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2023·2023-02-15

    Sterile endoscopy trays recalled for potential blade packaging puncture

    Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.

    Product
    Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2023·2023-02-15

    Sterile Procedural Trays recalled for potential blade puncture of packaging

    Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.

    Product
    Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Compromise

    Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2023·2023-02-15

    Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.

    Product
    Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Packaging Puncture

    Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.

    Product
    Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging

    Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.

    Product
    Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.

    Product
    Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2023·2023-02-15

    Sterile Procedural Trays Recalled Due to Blade Puncture Risk

    Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units distributed nationwide and internationally.

    Product
    Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2023·2023-02-08

    Non-sterile procedural knee trays recalled for potential packaging breach

    Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.

    Product
    Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2023·2023-02-08

    Non-sterile procedural trays with potential sterile packaging breach

    Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.

    Product
    Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0219-2023·2023-02-01

    Injectable Magnesium Chloride Recalled Due to Facility Contamination Concerns

    Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable (5 mL vials) distributed nationwide due to insanitary facility conditions that compromise product sterility assurance.

    Product
    MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2023·2023-01-18

    Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging

    International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.

    Product
    Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer…
    Category
    Medical Device
    Distribution
    Distributed nationwide