The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

5901–5925 of 21595

  • ModerateFDA (Devices)·Z-1486-2021·2021-05-05

    Cardiac Assist Recalls Incorrectly Packaged Protek Solo Venous Dilator Sets

    Cardiac Assist, Inc. is recalling 13 Protek Solo Venous Dilator Sets due to incorrect packaging discovered in finished goods.

    Product
    Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1497-2021·2021-05-05

    Siemens Recalls ARTIS X-Ray Systems Due to Software Issue

    Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.

    Product
    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2021·2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab may fail. The recall covers units distributed in the US and several international countries.

    Product
    DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1515-2021·2021-05-05

    Smiths Medical Recalls Palm Cups Due to Incorrect Shipping Box Labels

    Smiths Medical ASD Inc. is recalling 682 Palm Cups because shipping box labels may be incorrect. The devices are intended to mobilize bronchial secretions.

    Product
    Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2021·2021-04-28

    Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance

    Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.

    Product
    ELI 380 Electrocardiograph, with 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-1484-2021·2021-04-28

    Welch Allyn Surveyor Bedside Patient Monitor Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 213 Surveyor S12/S19 Bedside Patient Monitors because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    Surveyor S12/S19 Bedside Patient Monitor, with 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-1431-2021·2021-04-28

    Bard Clean-Cath Intermittent Catheter Recalled for Packaging and Tip Defects

    C.R. Bard is recalling 9,800 units of Bard Clean-Cath Intermittent Catheters because the catheter tip was cut off and the packaging was not fully sealed.

    Product
    Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Recall

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1432-2021·2021-04-28

    Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors

    Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.

    Product
    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2021·2021-04-28

    Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns

    Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.

    Product
    Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2021·2021-04-28

    Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error

    Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size device.

    Product
    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0445-2021·2021-04-28

    Thai Home Satay Peanut Sauce Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling Thai Home brand Satay Peanut Sauce due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Satay Peanut Sauce packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004078 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 SE
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1436-2021·2021-04-28

    Stryker DirectInject Bone Cement Recalled Due to Injection Failure

    Stryker is recalling 321 units of DirectInject bone cement because the paste cannot be injected from the syringe into the target location.

    Product
    DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0446-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Dyes and Unapproved Colorant

    USA LANKA INC is recalling Motha Jelly Crystals because the product contains undeclared FD&C yellow #5 and blue #1, as well as the unapproved dye carmoisine.

    Product
    Motha Jelly Crystals - Mixed Fruit Flavoured Jelly, Net Wt. 100g,
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0444-2021·2021-04-28

    Thai Home Mussaman Curry Paste Recalled for Elevated Water Activity

    Jansala & Foods LLC is recalling 105 cases of Thai Home brand Mussaman Curry Paste due to elevated water activity levels in shelf-stable products.

    Product
    Thai Home brand Mussaman Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004047 Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 [email protected] Distributed by: Earthly Gourmet 2143 S
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0450-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared FD&C Yellow #6

    USA LANKA INC is recalling Motha Jelly Crystals because the product contains undeclared FD&C Yellow #6, a food dye.

    Product
    Motha Jelly Crystals - Orange Flavoured Jelly, Net Wt. 100g
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0336-2021·2021-04-28

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects

    Noven Pharmaceuticals is recalling Minivelle estradiol transdermal patches because the adhesive may not stick well to the skin.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1433-2021·2021-04-28

    Boston Scientific AMS 700 Penile Prosthesis Reservoirs Recalled for Mislabeling

    Boston Scientific is recalling 23 AMS 700 penile prosthesis reservoirs because they were incorrectly labeled as a different model type.

    Product
    The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1482-2021·2021-04-28

    Welch Allyn ELI 280 Electrocardiograph Recalled for Safety Standard Non-Compliance

    Welch Allyn is recalling 99 ELI 280 Electrocardiographs because they do not meet IEC 60601-2-27 safety requirements as labeled.

    Product
    ELI 280 Electrocardiograph, with 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 (Food)·F-0449-2021·2021-04-28

    Motha Jelly Crystals Recalled for Undeclared Red Dye

    USA Lanka Inc. is recalling Motha Jelly Crystals Strawberry Flavoured Jelly because it contains undeclared FD&C Red #40.

    Product
    Motha Jelly Crystals Strawberry Flavoured Jelly , Net Wt. 100g
    Category
    Food
    Distribution
    10 states