The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.

1776–1800 of 2228

  • SevereFDA (Drugs)·D-1390-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 58 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1384-2015·2015-09-02

    Liberty Drug Recalls Papaverine/Phentolamine/PGE-1 Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable because process deficiencies may have compromised sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1382-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Methylcobalamin 5000 mcg/mL Injectable vials due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1385-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1380-2015·2015-09-02

    Liberty Drug Recalls Cyanocobalamin Syringes Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 syringes of Cyanocobalamin 500 mcg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2423-2015·2015-08-26

    International Biophysics Recalls IBC Aortic Punch Due to Seal Issues

    International Biophysics Corp. is recalling 10,330 units of IBC Aortic Punch because the heat seal on sterile pouches may not meet strength acceptance criteria.

    Product
    IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2015·2015-08-26

    International Biophysics Recalls IBC Suction Wands Due to Seal Defects

    International Biophysics Corp. is recalling 100 IBC Suction Wands because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2424-2015·2015-08-26

    International Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues

    International Biophysics Corp. is recalling 771 IBC Vascular Loops because heat seals on sterile pouches may not meet strength criteria.

    Product
    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2015·2015-08-26

    Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

    Product
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2015·2015-08-26

    Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns

    Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.

    Product
    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2428-2015·2015-08-26

    Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.

    Product
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2107-2015·2015-07-29

    FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves

    The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2015·2015-07-29

    FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves

    The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2015·2015-07-29

    FDA Recalls Sterile Surgical Kits with Compromised Gloves

    The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.

    Product
    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2116-2015·2015-07-29

    FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves

    The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.

    Product
    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2015·2015-07-29

    Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.

    Product
    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2015·2015-07-29

    FDA Recalls Devon Light Gloves for Sterility Compromising Defects

    The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.

    Product
    Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2015·2015-07-29

    Recall of Sterile Major Kits with Defective Devon Light Gloves

    FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.

    Product
    Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2015·2015-07-29

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2112-2015·2015-07-29

    Surgical Kits Recalled Due to Glove Splits Compromising Sterility

    The FDA is recalling 114,813 surgical kits containing Devon Light Gloves due to splits or holes that compromise sterility.

    Product
    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 74
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2015·2015-07-29

    Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2115-2015·2015-07-29

    FDA Recalls Sterile Single Basin Kits with Compromised Gloves

    The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2015·2015-07-29

    FDA Recalls Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling sterile Devon Light Gloves because splits or holes compromise their sterility. The recall covers 26,108,946 units distributed worldwide.

    Product
    Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2015·2015-07-29

    FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise

    FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.

    Product
    Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA
    Category
    Medical Device
    Distribution
    Distributed nationwide