The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

18951–18975 of 50407

  • HighFDA (Devices)·Z-0093-2022·2021-10-20

    Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors

    Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·040-2021·2021-10-20

    Mex-tamale Foods Recalls Beef and Pork Tamales for Undeclared Sesame

    Demaiz Inc. is recalling beef and pork tamales sold in Northern California because they contain sesame seeds, an allergen not listed on the label.

    Product
    Demaiz Inc. dba: Mextamale Foods — Demaiz Inc. Recalls Beef And Pork Tamale Products Due To Misbranding And Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0019-2022·2021-10-20

    Brownie Chocolate Walnuts Recalled for Undeclared Walnuts

    Kelly's Bakery Corp. is recalling Brownie Chocolate Walnuts because walnuts are not declared on the product label. Consumers with walnut allergies face a potential allergic reaction.

    Product
    Brownie Chocolate Walnuts, Carton with 96 retail units, A210107B
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0013-2022·2021-10-20

    Curly Parsley Recalled Due to Potential STEC Contamination

    Dole Fresh Vegetables is recalling curly parsley distributed to five U.S. states due to potential non-O157 STEC (Shiga-Toxin 1) contamination. Consumers should not consume the affected product.

    Product
    Bunches of curly parsley packed in cardboard cases received at distributor level with following labeling: Herb Parsley Curly Grown in Salinas 60EA x 60EA Bunch US or 30EA x 60EA Bunch US Dole Fresh Vegetables, Monterey, CA 93940 PLU 4899 0 07143 00310 Harvest Date Aug18…
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0011-2022·2021-10-20

    Green Field Farms Chocolate Milk Recall for Improper Pasteurization

    Green Field Farms Co-op is recalling chocolate milk products due to improper pasteurization. The affected products were distributed to Indiana, New Jersey, and Ohio.

    Product
    Green Field Farms Chocolate Milk 1/2 gallon glass jar, 6 units per case 53oz plastic bottle, 6 units per case 12oz plastic bottle, 8 units per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0085-2022·2021-10-20

    Spinal Implant Engraving May Not Match Pouch Labels

    Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.

    Product
    Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0103-2022·2021-10-20

    Smiths Medical Blood Sampling System Recalled for Pressure Malfunction and Incorrect Readings

    Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0115-2022·2021-10-20

    Elekta Medical Linear Accelerator Diode Failure Risk During Maintenance

    Elekta medical linear accelerators may have a defective diode that could fail destructively when removed, with risk of ejected debris. No injuries have been reported.

    Product
    Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0106-2022·2021-10-20

    Ion Flexison Biopsy Needle recalled for potential sheath tip separation

    Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.

    Product
    Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0094-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure measurement errors

    Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.

    Product
    smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0083-2022·2021-10-20

    Cobas EGFR Mutation Test v2 may return false mutation detection results

    The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.

    Product
    cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2022·2021-10-20

    Smiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors

    Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0116-2022·2021-10-20

    Elekta Medical Linear Accelerator Diode Component Destructive Failure Risk

    Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.

    Product
    Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2022·2021-10-20

    Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption

    A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.

    Product
    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2022·2021-10-20

    Gore VIABAHN VBX endoprosthesis recalled for incorrect device dimension labeling

    W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.

    Product
    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2022·2021-10-20

    Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

    Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

    Product
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2022·2021-10-20

    Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors

    Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.

    Product
    medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0086-2022·2021-10-20

    Endoskeleton TCS Interbody System implant engraving may not match pouch labels

    Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.

    Product
    Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0101-2022·2021-10-20

    Blood sampling system sets recalled for pressure reading and measurement errors

    Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.

    Product
    smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0098-2022·2021-10-20

    Medical Device Recall: Blood Sampling System Pressure and Reading Errors

    Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood collection accuracy.

    Product
    smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0082-2022·2021-10-20

    Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

    Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

    Product
    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2022·2021-10-20

    Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent

    Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.

    Product
    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0105-2022·2021-10-20

    Thoraguard Chest Tube Kit 20 Fr Recalled for Adhesive Joint Failure

    Centese Inc. is recalling Thoraguard Chest Tube Kits (20 Fr) because an adhesive joint in the SmartValve component can fail, causing fluid to leak. The affected kits were distributed to a single facility in California.

    Product
    Thoraguard Chest Tube Kit, 20 Fr
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0102-2022·2021-10-20

    Smiths Medical blood sampling system recalled for pressure reading errors

    Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.

    Product
    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
    Category
    Medical Device
    Distribution
    0 states