The Recall Desk

Hazard

Sterility Assurance recalls

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

What the numbers show

Total
663
Critical
0
Severe
261
Most recent
2026-08-26

Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance 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.

126–150 of 663

  • HighFDA (Drugs)·D-0258-2026·2026-01-21

    Testosterone pellets recalled over a lack of assurance of sterility

    Advanced Pharmaceutical Technology is recalling 22,843 TESTO-100 testosterone pellets over a lack of assurance of sterility and potential microbial contamination.

    Product
    TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0243-2026·2026-01-07

    ChloraPrep triple swabsticks recalled over lack of assurance of sterility

    CareFusion 213 is recalling 106,400 units of BD ChloraPrep Triple Swabsticks over a lack of assurance of sterility.

    Product
    CHLORAPREP SWABSTICK — CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0143-2026·2025-11-05

    Sodium chloride injection bags recalled over potential flexible container leaks

    Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0118-2026·2025-11-05

    Semaglutide 2.5 mg vials recalled for lack of sterility assurance

    ProRx is recalling 2,649 vials of Semaglutide Injection 2.5 mg/1 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0116-2026·2025-11-05

    Semaglutide 6 mg vials recalled for lack of sterility assurance

    ProRx is recalling 8,310 vials of Semaglutide Injection 6 mg/2.4 mL across three lots for lack of assurance of sterility.

    Product
    Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0119-2026·2025-11-05

    Semaglutide 5 mg vials recalled for lack of sterility assurance

    ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0117-2026·2025-11-05

    Semaglutide 8 mg vials recalled for lack of sterility assurance

    ProRx is recalling 11,119 vials of Semaglutide Injection 8 mg/3.2 mL across four lots for lack of assurance of sterility.

    Product
    Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0099-2026·2025-11-05

    Adalimumab prefilled syringes recalled for lack of sterility assurance

    Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.

    Product
    HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0120-2026·2025-11-05

    Compounded tirzepatide vials recalled for lack of sterility assurance

    ProRx is recalling 2,761 vials of Tirzepatide Injection 27 mg/3 mL from one lot for lack of assurance of sterility.

    Product
    Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0115-2026·2025-11-05

    Semaglutide 10 mg vials recalled for lack of sterility assurance

    ProRx is recalling 8,400 vials of Semaglutide Injection 10 mg/4 mL for lack of assurance of sterility.

    Product
    Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0114-2026·2025-11-05

    Compounded semaglutide vials recalled for lack of sterility assurance

    ProRx is recalling 2,809 vials of Semaglutide Injection 12.5 mg/5 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0097-2026·2025-10-29

    Opdualag injection vials recalled from one lot over sterility assurance

    Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection from one lot for lack of assurance of sterility.

    Product
    OPDUALAG — OPDUALAG (NIVOLUMAB AND RELATLIMAB-RMBW)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2026·2025-10-22

    Head and neck procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling ENT and head and neck convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2026·2025-10-22

    Biopsy and laparoscopy packs recalled after being sterilized more than once

    American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2026·2025-10-22

    Cardiac catheterization packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2026·2025-10-22

    Spine and laminectomy packs recalled after being sterilized more than once

    American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2026·2025-10-22

    Basic biopsy trays recalled after entire lot was sterilized more than once

    American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray, Item Number NMBP44L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2026·2025-10-22

    Angiography procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

    American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2026·2025-10-22

    Central line insertion kits recalled after being sterilized more than once

    American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.

    Product
    Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2026·2025-10-22

    General and laparotomy packs recalled after being sterilized more than once

    American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.

    Product
    Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2026·2025-10-22

    Dilation and curettage packs recalled after being sterilized more than once

    American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits IHDC30R D AND C PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2026·2025-10-22

    Cardiovascular procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2026·2025-10-22

    Orthopedic procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IAS
    Category
    Medical Device
    Distribution
    Distributed nationwide