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.

7376–7400 of 21595

  • ModerateFDA (Devices)·Z-1234-2020·2020-02-26

    Medicrea Universal Counter Torque Recalled Due to Incompatibility with Nut Driver

    Medicrea International is recalling 3 units of Universal Counter Torque for the Pass TULIP Spinal System because they are incompatible with the T30 nut driver.

    Product
    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1243-2020·2020-02-26

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 140 units of Central Venous Catheterization Kits because the product lidstock contains the incorrect expiration date.

    Product
    Arrow Central Venous Catheterization Kit ASK-04200-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2020·2020-02-26

    Ormco/Sybronendo Recalls SnapLink Brackets Due to Slide Door Failure

    Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.

    Product
    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1292-2020·2020-02-26

    Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2020·2020-02-26

    Siemens ADVIA Chemistry Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.

    Product
    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1334-2020·2020-02-26

    Ethicon Recalls Three Stratafix Suture Units for Internal Testing Failures

    Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1277-2020·2020-02-26

    Polysorb Suture Recall Due to Packaging Integrity Issues

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2020·2020-02-26

    Abbott i-STAT CHEM8+ Cartridges Recalled for Lack of FDA Clearance

    Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.

    Product
    i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0735-2020·2020-02-26

    Pepper Source Recalls Mississippi Mash BBQ Sauce for Packing Material

    Pepper Source, Ltd. is recalling specific lots of Mississippi Mash BBQ Sauce because the product may contain pieces of food grade packing material.

    Product
    PS# 86293 Mississippi Mash BBQ Sauce 30 Packs/ 20.2 oz. Net WT 37.88 each Carton and PS# 86295 Mississippi Mash BBQ Sauce (20.2 oz. packs) 30 Packs/Case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1323-2020·2020-02-26

    Nobel Biocare Recalls Implant Retrieval Kits Due to Sterility Concerns

    Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their shelf-life.

    Product
    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 2,470 implant retrieval instruments because a packaging defect may compromise sterility. The devices are distributed worldwide.

    Product
    Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2020·2020-02-26

    Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 8 Dense Bone Drills because a packaging defect may compromise sterility during shelf life.

    Product
    Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2020·2020-02-26

    FDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 160 units of the Arrow Epidural Catheterization Kit (YC-02220) because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION KIT YC-02220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0721-2020·2020-02-26

    CSM Bakery Recalls Frozen Cookie Dough Due to Plastic Contamination

    CSM Bakery Products is recalling frozen chocolate chip cookie dough because pieces of plastic polymer were introduced into the sugar system.

    Product
    30 lb. cases of 480 1.0 oz frozen chocolate chip with mini colored candy pieces cookie dough, MDM # 10194626, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0771-2020·2020-02-26

    Suja Organic Mango Mojito Smoothie Recalled for Unapproved Herbicide

    Suja Life LLC is recalling 6,817 bottles of Organic Mango Mojito Fruit + Veggie Smoothie due to the presence of an unapproved herbicide in raw flax material.

    Product
    Suja Organic Mango Mojito Fruit + Veggie Smoothie, 12 oz. UPC: 81861702240
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1245-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 870 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.

    Product
    Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2020·2020-02-26

    American Health Packaging Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

    American Health Packaging is recalling Desmopressin Acetate Tablets because product bottles may be missing desiccant.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0768-2020·2020-02-26

    Don Lee Farms Chipotle Black Bean Burgers Recalled for Unapproved Herbicide

    Don Lee Farms is recalling specific lots of Chipotle Black Bean and Black Burgers because an ingredient was grown using an unapproved herbicide.

    Product
    Don Lee Farms Chipotle Black Bean Burger 12 pack/3Lbs. cartons UPC 087427438135, Item 1372617 Don Lee Farms Chipotle Black Burger 10 pack/2.5 lb. cartons UPC 087427430757/Item 997176SF
    Category
    Food
    Distribution
    6 states