The Recall Desk

Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total
536
Critical
0
Severe
56
Most recent
2026-07-01

Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) 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 regulatory non compliance 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.

1–25 of 536

  • SevereFDA (Devices)·Z-2582-2026·2026-07-01

    Medline polycarbonate syringes recalled for unapproved design changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2585-2026·2026-07-01

    Medline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2589-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA clearance. The affected kits have been distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2026·2026-07-01

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2026·2026-07-01

    Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2596-2026·2026-07-01

    Medline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2595-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2026·2026-05-13

    One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.

    Product
    One Step 10A in vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1878-2026·2026-04-29

    Medline Convenience Kits with Colored Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling multiple Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects products distributed worldwide including the US, Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1890-2026·2026-04-29

    Medline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled

    Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2026·2026-04-29

    Medline 10mL Polycarbonate Syringes in Convenience Kits recalled

    Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ022088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1879-2026·2026-04-29

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2026·2026-04-29

    Medline Catheterization and Angiography Kits Regulatory Clearance Rescinded

    Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.

    Product
    Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT57
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2026·2026-04-29

    Medline Breast Pack Kit regulatory clearance rescinded by FDA

    The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.

    Product
    Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1848-2026·2026-04-29

    Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances

    Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2026·2026-04-29

    Medline Medical Device Kits Recall for Loss of 510(k) Clearance

    Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.

    Product
    Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1888-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes recalled for unapproved design changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2026·2026-04-29

    Medline Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA clearance. The recall affects 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2025·2025-07-02

    Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance

    Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.

    Product
    Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1878-2025·2025-06-11

    Lazervida 10W Diode Laser Engraver Does Not Meet Federal Safety Standards

    Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.

    Product
    Lazervida 10W diode laser cutter and engraver with Lazervida shield.
    Category
    Medical Device
    Distribution
    0 states
  • SevereUSDA FSIS·014-2025·2025-05-02

    Ferrarini USA Recalls Ready-to-Eat Prosciutto for Import Violation

    Ferrarini USA is recalling approximately 70 pounds of ready-to-eat sliced prosciutto imported without required reinspection. No illnesses have been reported.

    Product
    Ferrarini USA, Inc., Recalls Ready-to-Eat Prosciutto Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1017-2025·2025-01-29

    Randox Lipoprotein (a) assay distributed without required FDA clearance

    Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance

    Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.

    Product
    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide