The Recall Desk

Hazard

Sterilization Failure recalls

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

What the numbers show

Total
574
Critical
3
Severe
34
Most recent
2026-07-22

Of the 574 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (6%) 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 sterilization failure 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.

101–125 of 574

  • HighFDA (Devices)·Z-0818-2024·2024-02-07

    Cardiac surgical kits recalled due to improper sterilization exposure

    American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.

    Product
    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2024·2024-02-07

    Surgical Procedure Kits Recalled Due to Improper Sterilization

    American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2024·2024-02-07

    Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure

    American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2024·2024-02-07

    Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure

    American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2024·2024-01-03

    Atrium Oasis surgical drain recalled for premature sterilization expiration

    Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.

    Product
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2024·2023-12-20

    Sterile PVP Solution Kit Recalled for Non-Sterile Contents

    Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.

    Product
    STERILE PVP SLN KIT, REF DYNDM1097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2024·2023-12-13

    Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance

    Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.

    Product
    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0415-2024·2023-12-06

    Olympus colonoscope repair defect may impair imaging and suction function

    Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.

    Product
    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0330-2024·2023-11-29

    Choleodochoscope Models Recalled Due to Unvalidated Air Drying Process

    Aizu Olympus choleodochoscopes with unvalidated air drying processes may retain water in the channel after repair, risking microbial contamination and patient infection. Affected models: CHF-BP30, CHF-CB30L, CHF-P60.

    Product
    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2024·2023-11-15

    EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures

    Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.

    Product
    EVIS EXERA III Gastrointestinal Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2024·2023-11-01

    Cath Cardiac Pack sterilization failure may cause loss of functionality

    American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.

    Product
    Cath Cardiac Pack, REF IHCC03V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0286-2024·2023-10-25

    Sweet Potatoes Recalled Due to Processing Equipment Failure

    Moody Dunbar Inc recalls HEB and Sysco brand sweet potatoes because a sterilization monitoring chart malfunctioned during production, preventing verification of adequate heat treatment.

    Product
    Sweet Potatoes sold under the brand names: HEB CUT SWEET POTATOES IN LIGHT SYRUP NET WT. 29 OZ (1 LB 13 OZ) 822g MADE WITH PRIDE AND CARE FOR HEB, SAN ANTONIO, TEXAS 78204 UPC 0 41220 45933 9 & SYSCO Classic Cut Sweet Potatoes NET WT/PESO NETO 108 OZ (6 LB 12 OZ) 3.06 kg DISTRIBU
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2604-2023·2023-09-27

    DJO Surgical Orthopedic Implants Recalled for Sterilization Failure

    DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.

    Product
    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2603-2023·2023-09-27

    Orthopedic knee implant component lacks final sterilization before shipment

    Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision surgery.

    Product
    DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Drugs)·D-1110-2023·2023-09-06

    Cardioplegia Solution Recalled for Unvalidated Sterilization Process

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1132-2023·2023-09-06

    Sterile Injectable Drug Recall: oxyTOCIN in Lactated Ringer's IV Bags

    Central Admixture Pharmacy Services is recalling 1,996 bags of oxyTOCIN in Lactated Ringer's IV bags because the company cannot assure the products are sterile. The firm lacks validation data for its sanitization procedures.

    Product
    oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1060-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.

    Product
    HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1079-2023·2023-08-09

    Fentanyl Injectable Recalled Due to Unvalidated Sterilization Process

    Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.

    Product
    fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1080-2023·2023-08-09

    Morphine Injectable Recalled Due to Unvalidated Sterilization Process

    Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising sterility.

    Product
    morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0983-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.

    Product
    oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1036-2023·2023-08-09

    Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency

    Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.

    Product
    CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
    Category
    Drug
    Distribution
    Distributed nationwide