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.

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 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.

101–125 of 536

  • SevereFDA (Devices)·Z-0568-2022·2022-02-23

    RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance

    BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.

    Product
    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2022·2022-02-18

    Corfu Foods Recalls Swai Fillets Imported Without Reinspection

    Corfu Foods is recalling 6,570 pounds of frozen swai fillets imported from Vietnam without required reinspection. No illnesses have been reported.

    Product
    Corfu Foods, Inc. Recalls Swai (Siluriformes) Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0384-2022·2021-12-22

    BioGlue Surgical Adhesive recalled for unauthorized distribution in European Union

    CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.

    Product
    BioGlue Surgical Adhesive, Model BG3510-5-G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2021·2021-08-25

    HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling

    Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.

    Product
    HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0911-2021·2021-08-25

    HiPP Dutch Stage 2 Infant Formula Missing Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling statements.

    Product
    HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0927-2021·2021-08-25

    Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling

    Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.

    Product
    Kendamil Organic Stage 2 Follow on Milk Formula
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0915-2021·2021-08-25

    HiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling

    Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.

    Product
    HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0920-2021·2021-08-25

    Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification

    Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.

    Product
    Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0912-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2227-2021·2021-08-18

    CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance

    Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.

    Product
    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2177-2021·2021-08-11

    FDA Recalls IUI Kit and Metal Speculum for Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.

    Product
    Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2070-2021·2021-07-21

    Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance

    Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.

    Product
    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2068-2021·2021-07-21

    Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance

    Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.

    Product
    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2021·2021-07-21

    Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance

    Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.

    Product
    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2021·2021-06-30

    Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.

    Product
    6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1908-2021·2021-06-30

    Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.

    Product
    Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1916-2021·2021-06-30

    Transducer Cover Lacks FDA 510(k) Clearance for Surgical Use

    Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1918-2021·2021-06-30

    Hays Ultrasound Kit Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Hays Ultrasound kit Item ID: H1000SE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1923-2021·2021-06-30

    Ultrasound probe covers recalled for missing required FDA 510k clearance

    Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.

    Product
    Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1907-2021·2021-06-30

    Ultrasonic Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Food)·F-0474-2021·2021-05-12

    Thai Home Sweet Chili Paste Recalled for Acidified Food Rule Violations

    Jansala & Foods LLC is recalling Thai Home Sweet Chili Paste for failing to follow acidified food regulations. The product was distributed to retailers in California, Oregon, and Washington.

    Product
    Thai Home brand Sweet Chili Paste (Num Prik Pao) packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004054 Manufactured by: Jansala & Foods LLC 1813 NE 2nd Avenue Portland, OR [email protected] Distributed by: Earthly Gourmet 2143
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1485-2021·2021-04-28

    Welch Allyn AM12M Acquisition Module Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 746 AM12M Acquisition Modules because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1362-2021·2021-04-14

    Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
    Category
    Medical Device
    Distribution
    0 states