The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 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.

451–475 of 1691

  • HighFDA (Devices)·Z-1901-2021·2021-06-30

    Sterile Colorectal Anoscopes and Proctoscopes Recalled Due to Falsified Sterilization Records

    Adler MicroMed recalls 1,858 sterile colorectal anoscopes and proctoscopes due to falsified sterilization records by the service provider, raising concerns about product sterility.

    Product
    Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1841-2021·2021-06-16

    Medline Tissue Recovery Instrument Sets Recalled for Sterility Assurance Failure

    Medline Industries is recalling Tissue Recovery Instrument Sets due to failure to meet sterility assurance levels. The instruments, used for tissue recovery in medical research and transplantation, were distributed in Wisconsin.

    Product
    Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1776-2021·2021-06-09

    Oral Surgery Scrapers Recalled Due to Potential Sterility Failure

    Meta C.G.M. Spa is recalling the REF 3987 SafeScraper Curve Twist oral surgical scrapers distributed in Texas and Florida due to sterility concerns. The single-use sterile devices may not have been adequately sterilized.

    Product
    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1633-2021·2021-05-26

    BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

    BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

    Product
    BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2021·2021-05-26

    Biopsybell 10 Gauge Direct Unilateral Stylets Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 625 units of 10 Gauge Direct Unilateral Stylets because they were labeled as sterile but may not have been sterilized.

    Product
    10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2021·2021-05-26

    Biopsybell Cement Mixing System Recalled for Potential Sterility Failure

    Biopsybell S.R.L. is recalling 500 units of the Cement Mixing System, Vertebroplasty-Kyphoplasty, Ref VCF-1051, because products labeled as sterile may not have been sterilized.

    Product
    CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns

    Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2021·2021-05-26

    Biopsybell 11G Direct Single Access Devices Recalled for Sterility Concerns

    Biopsybell is recalling 50 units of 11G Direct Single Access devices labeled as sterile but potentially not sterilized, distributed in Mississippi and Kentucky.

    Product
    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2021·2021-05-26

    Biopsybell 11G Direct Working Cannula Recalled for Sterility Concerns

    Biopsybell is recalling 75 units of 11G Direct Working Cannula Diamond Tip Mini because they were labeled sterile but may not have been sterilized.

    Product
    11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2021·2021-05-26

    BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile may not have been sterilized.

    Product
    BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2021·2021-05-26

    Biopsybell 11G Direct Single Delivery Kits Recalled for Sterility Concerns

    Biopsybell is recalling 160 units of 11G Direct Single Delivery kits because they were labeled as sterile but may not have been sterilized.

    Product
    11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2021·2021-05-26

    BPB medica Osteobell Explant Needle Recalled for Sterility Concerns

    BPB medica is recalling Osteobell Explant Needles because they were labeled as sterile but may not have been sterilized.

    Product
    BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2021·2021-05-26

    Biopsybell 8G Direct Working Cannula Bevel Tip Recalled for Sterility Concerns

    Biopsybell S.R.L. is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile but potentially not sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.

    Product
    8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2021·2021-05-26

    Biopsybell Cement Delivery Kits Recalled for Potential Sterility Failure

    Biopsybell is recalling 305 units of 10 Gauge Single Cement Delivery kits because they were labeled sterile but may not have been sterilized.

    Product
    10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2021·2021-05-26

    Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure

    Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.

    Product
    10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2021·2021-05-26

    Biopsybell Easynject Device Recalled for Potential Sterility Failure

    Biopsybell is recalling five Easynject vertebroplasty devices because they were labeled sterile but may not have been sterilized.

    Product
    EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0281-2021·2021-03-03

    Teva Recalls MethyIPREDNISolone Acetate Injectable Suspension Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of MethyIPREDNISolone Acetate Injectable Suspension because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2021·2021-03-03

    Teva Recalls Dacarbazine Injection Due to Sterility Assurance Concerns

    Teva Pharmaceuticals is recalling Dacarbazine for Injection USP because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.

    Product
    Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0273-2021·2021-03-03

    Teva Recalls Sterile Diluent for Epoprostenol Sodium Due to Sterility Concerns

    Teva Pharmaceuticals is recalling specific lots of Sterile Diluent for Epoprostenol Sodium for Injection because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2021·2021-03-03

    Teva Recalls Leucovorin Calcium Injection Due to Sterility Concerns

    Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection because manufacturing areas exceeded microbial recovery levels, compromising sterility assurance.

    Product
    Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0278-2021·2021-03-03

    Teva Recalls Toposar Etoposide Injection Due to Sterility Assurance Issues

    Teva Pharmaceuticals is recalling Toposar (etoposide) injection vials because manufacturing areas exceeded microbial acceptance levels, compromising sterility assurance.

    Product
    Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.
    Category
    Drug
    Distribution
    Distributed nationwide