The Recall Desk

Hazard

Out Of Specification recalls

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

About this hazard tag

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

26–50 of 161

  • HighFDA (Devices)·Z-2505-2026·2026-06-24

    Medline gynaecology procedure packs contain catheters failing performance specifications

    Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2026·2026-06-24

    Medline D and C and cardiovascular packs contain substandard catheters

    Medline D and C Packs and a custom cardiovascular pack are being recalled because representative samples did not meet applicable catheter performance specifications. 168 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2482-2026·2026-06-24

    Medline red rubber urethral catheterization trays fail performance specifications

    Medline Urethral Catheterization Trays with red rubber latex catheter, 15 Fr, are being recalled across all lots because samples did not meet performance specifications. 235,658 units affected.

    Product
    MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2026·2026-06-24

    Medline carotid neuro and VP shunt packs contain substandard catheters

    Medline Carotid Neuro Packs and VP Shunt CDS kits are being recalled because representative samples did not meet applicable catheter performance specifications. 342 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2026·2026-06-24

    Medline Robinson 22 Fr catheter packs fail performance specifications

    Medline CATH 22F Robinson sterile 5-packs are being recalled because representative samples did not meet applicable catheter performance specifications. 1,000 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2026·2026-06-24

    Medline cardiovascular draping and basin kits contain substandard catheters

    Medline CV Draping/Basin procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 1,432 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2484-2026·2026-06-24

    Medline coude latex catheters fail applicable performance specifications

    Medline Intermittent Latex Coude Catheters pre-connected to a collection bag, 16 Fr, are being recalled across all lots because samples did not meet performance specifications. 10,980 units affected.

    Product
    MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2026·2026-06-24

    Medline vasectomy reversal kits contain catheters failing performance specifications

    Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0590-2026·2026-06-24

    Kerr Insta-Char aqueous charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char in an aqueous base, 50 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2026·2026-06-24

    Kerr Insta-Char 50 gram charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char, 50 grams activated charcoal in a sorbitol base, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2026·2026-06-24

    Kerr Insta-Char activated charcoal suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char activated charcoal in a sorbitol base with cherry flavor is being recalled because the product did not meet the Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0588-2026·2026-06-24

    Alyacen 7/7/7 birth control tablets failed total impurities specification

    Alyacen 7/7/7 norethindrone and ethinyl estradiol tablets are being recalled because of out-of-specification results for total impurities.

    Product
    ALYACEN 1/35 — ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0589-2026·2026-06-24

    Kerr Insta-Char 25 gram aqueous suspension did not meet OTC monograph

    VistaPharm Kerr Insta-Char in an aqueous base, 25 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.

    Product
    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0587-2026·2026-06-17

    Niacin extended-release tablets failed dissolution testing at 24 hours

    GSMS Niacin Extended-Release Tablets, USP, 1,000 mg, are being recalled after a lot was out of specification for stage 3 dissolution at the 24-hour timepoint. 2,961 bottles affected.

    Product
    NIACIN — NIACIN (NIACIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0597-2026·2026-06-17

    Minocycline extended-release tablets failed dissolution testing during stability analysis

    Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.

    Product
    MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2026·2026-06-03

    Halyard nitrile exam gloves failed chemical permeation performance specifications

    Halyard Purezero Ultraviolet Nitrile Exam Gloves are being recalled because they failed to meet specifications for chemical permeation performance. 452,500 units are affected.

    Product
    Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0551-2026·2026-06-03

    Pred Mild prednisolone eye suspension failed stability specifications

    Pred Mild prednisolone acetate ophthalmic suspension 0.12% is being recalled after failing stability specifications. 2,736 bottles are affected.

    Product
    PRED MILD — PRED MILD (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2021-2026·2026-05-06

    Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.

    Product
    Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2030-2026·2026-05-06

    Medline Microdisectomy Kits Recalled for High Endotoxin Levels

    Medline is recalling Microdisectomy Packs containing Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review. The affected products may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2035-2026·2026-05-06

    Medline robotic hysterectomy procedure kits recalled for elevated endotoxin

    Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2014-2026·2026-05-06

    Medline Neuro Sponges in Medical Procedure Kits Recalled for Endotoxin

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
    Category
    Medical Device
    Distribution
    0 states