The Recall Desk

Hazard

Sterility Failure recalls

1,693 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,693
Critical
12
Severe
938
Most recent
2026-09-30

Of the 1,693 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 938 (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.

501–525 of 1693

  • HighFDA (Devices)·Z-1053-2021·2021-02-17

    Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-210U-15 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2021·2021-02-17

    Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals

    Aomori Olympus is recalling NA-411D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2021·2021-02-17

    Aomori Olympus Recalls K-204 Guide Sheath Kits Due to Seal Defects

    Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2021·2021-02-17

    Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects

    Aomori Olympus is recalling ViziShot 22G aspiration needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2021·2021-02-17

    Aomori Olympus NeedleMaster Endoscopic Injection Needles Recalled for Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.

    Product
    NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2021·2021-02-17

    Aomori Olympus Recalls KD-611L Electrosurgical Knives Due to Seal Defects

    Aomori Olympus is recalling KD-611L electrosurgical knives because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2021·2021-02-17

    Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects

    Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2021·2021-02-17

    Aomori Olympus ForceMax Endoscopic Injectors Recalled for Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles for Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages had inadequate seals, posing an infection risk if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2021·2021-02-17

    Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals

    Aomori Olympus is recalling biliary stents because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1021-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects

    Aomori Olympus is recalling 260,395 NeedleMaster needles in the US because some sterile packages have inadequate seals, posing an infection risk.

    Product
    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2021·2021-02-17

    Aomori Olympus Recalls KD-650L Electrosurgical Snare Due to Seal Defects

    Aomori Olympus Co., Ltd. is recalling KD-650L Electrosurgical Snare units because some sterile packages have inadequate seals, posing an infection risk.

    Product
    KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2021·2021-02-17

    Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals

    Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.

    Product
    INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2021·2021-02-17

    Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects

    Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1002-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if used.

    Product
    INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2021·2021-02-17

    Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals

    Aomori Olympus is recalling SD-210U-25 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection.

    Product
    SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2021·2021-02-17

    Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects

    Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.

    Product
    INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2021·2021-01-27

    Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns

    Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.

    Product
    Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2021·2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,239 syringes of Succinylcholine Chloride 200 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
    Category
    Drug
    Distribution
    Distributed nationwide