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.

6601–6625 of 21595

  • ModerateFDA (Devices)·Z-2804-2020·2020-08-19

    Arrow International Recalls NextStep Retrograde Replacement Hub Set Due to Labeling Error

    Arrow International is recalling NextStep Retrograde Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2779-2020·2020-08-19

    HealthFirst STAT KIT Z-1000 Emergency Medical Kits Recalled for Missing Component

    HF Acquisition Co. LLC is recalling two STAT KIT Z-1000 emergency medical kits because they are missing a hand suction pump component.

    Product
    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1502-2020·2020-08-19

    Lupin Recalls Mibelas 24 Fe Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling Mibelas 24 Fe chewable tablets because they failed impurity specifications. The recall covers 560,922 pouches distributed nationwide.

    Product
    Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1152-2020·2020-08-19

    Indianapolis Fruit Company Recalls Garden Cut Organic Coleslaw Due to Plastic

    Indianapolis Fruit Company is recalling Garden Cut Organic Coleslaw w/ Carrots because pieces of plastic were found in the finished product.

    Product
    Garden Cut Organic Coleslaw w/ Carrots, retail unit packaged in 1lb clam-shell, 4 retail units per wholesale case, retail unit UPC: 053495081016
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2802-2020·2020-08-19

    Arrow International Recalls Cannon II Plus Replacement Hub Sets for Labeling Error

    Arrow International Inc is recalling Cannon II Plus Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2797-2020·2020-08-19

    Wright Medical Screw Removal Case Assembly Recalled for Missing Drivers

    Wright Medical Technology is recalling 9 units of the Screw Removal Case Assembly because the kits do not include drivers required to remove specific headless screws.

    Product
    Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2782-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2020·2020-08-19

    Wright Medical Hardware Removal Kit Recalled for Missing Drivers

    Wright Medical Technology is recalling 66 hardware removal kits because they lack the specific drivers needed to remove Dart-Fire 2.5 and 3.0mm Headless screws.

    Product
    Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1154-2020·2020-08-19

    Hostess Raspberry Zingers Recalled for Potential Mold Growth

    Hostess Brands is recalling 34,409 cases of Raspberry Zingers cakes nationwide due to potential mold growth prior to the best-by date.

    Product
    Hostess Raspberry Zingers, Raspberry Iced Cake With Creamy Fillling, packaged in the following ways: 1) in boxes containing 10 cakes Net Wt. 13.4 OZ (380 g) UPC 88109110604 and 2) in clear plastic bags containing 3 cakes Net Wt. 4.02 OZ (114 g) UPC 888109010089
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2786-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1156-2020·2020-08-19

    Strongbrew Cold Brew Coffee Recalled for Lack of Refrigeration

    Uncommon Canning LLC is recalling Strongbrew Cold Brew Coffee because it was not stored under refrigeration prior to shipment.

    Product
    Strongbrew Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 898577002141
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2777-2020·2020-08-19

    Smith & Nephew Recalls Misidentified PeriLoc Targeter Handle

    Smith & Nephew is recalling 3 units of a PeriLoc Targeter handle that was incorrectly marked as a left-hand part.

    Product
    PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2788-2020·2020-08-19

    HealthFirst Emergency Medical Kit Recalled for Missing Narcan Dose

    HF Acquisition Co. is recalling HealthFirst Emergency Medical Kits because they contain one dose of Narcan nasal spray instead of two.

    Product
    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1498-2020·2020-08-19

    Eosera Recalls Ear Pain MD Pain Relief Drops For Kids

    Eosera, Inc. is voluntarily recalling 45,673 bottles of Ear Pain MD Pain Relief Drops For Kids due to cGMP deviations.

    Product
    Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2792-2020·2020-08-19

    Brainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration

    Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.

    Product
    BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2772-2020·2020-08-19

    NeuroLogica OmniTom CT Systems Recalled for Operational Shutdown Issues

    NeuroLogica is recalling 35 OmniTom CT systems due to potential operational issues that could cause inadvertent shutdowns and delays in patient treatment.

    Product
    OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2789-2020·2020-08-19

    HF Acquisition Recalls Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling 95 STAT KIT Model SM30 emergency medical kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1492-2020·2020-08-19

    Teva Recalls Lidocaine Patches Due to Missing Lot and Expiration Dates

    Teva Pharmaceuticals is recalling Lidocaine 5% Patches because individual pouches are missing lot and expiration dates. The recall covers 28,596 cartons distributed nationwide.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2783-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2020·2020-08-19

    Arrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling TheraCath Epidural Catheters because the lidstock displays an incorrect expiration date, potentially leading to the use of expired devices.

    Product
    Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2787-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 Calcaneus Plates, Extensile, Large, Right (Catalog Number CPF 203) because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2790-2020·2020-08-19

    HF Acquisition Recalls STAT KIT 550 Emergency Medical Kits

    HF Acquisition Co., LLC is recalling 155 STAT KIT Model 550 Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2791-2020·2020-08-19

    HF Acquisition Recalls STAT KIT Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling STAT KIT Model 550AI Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-1499-2020·2020-08-19

    Eosera Recalls Ear Pain MD Pain Relief Drops Due to cGMP Deviations

    Eosera, Inc. is voluntarily recalling 125,874 bottles of Ear Pain MD Pain Relief Drops with 4% Lidocaine due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
    Category
    Drug
    Distribution
    Distributed nationwide