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.

8076–8100 of 21595

  • ModerateFDA (Devices)·Z-2547-2019·2019-09-25

    Philips IntelliVue Remote Antenna Cable Recalled for Incorrect Rating

    Philips is recalling IntelliVue 1.4 GHz Remote Antenna cables used with MX40 monitors because they lack the required rating for some installations.

    Product
    IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2147-2019·2019-09-18

    Cracked Pepper Chicken of the Sea Salmon Recalled for Bloating

    Tri-Union Frozen Products is recalling Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon pouches due to microbial spoilage causing bloating.

    Product
    Cracked Pepper Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 and 0 480000 11817 7 individual pouch; UPC 1 00 48000 01179 1 - Case Chicken of the Sea International El Segundo, CA Product of Th
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2495-2019·2019-09-18

    Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue

    Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.

    Product
    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2153-2019·2019-09-18

    Abbott Recalls Similac Pro-Sensitive Bottles Due to Packaging Error

    Abbott Nutrition is recalling specific cartons of Similac Pro-Sensitive that may contain Similac Pro-Advance bottles due to a packaging error.

    Product
    Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2538-2019·2019-09-18

    Smith & Nephew Recalls Legion Hemi Step Tibial Wedge Due to Packaging Error

    Smith & Nephew is recalling 12 units of Legion Hemi Step Tibial Wedges because they were inadvertently packaged with an incorrect screw component.

    Product
    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2499-2019·2019-09-18

    Exactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism

    Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.

    Product
    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2488-2019·2019-09-18

    Philips Recalls Two HeartStart MRx Monitor/Defibrillators for Missing Corrections

    Philips North America, LLC is recalling two HeartStart MRx Monitor/Defibrillators because they may not have received applicable corrections from prior field actions.

    Product
    HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2151-2019·2019-09-18

    FungusAmongUs Shiitake Organic Mushrooms Recalled for Undeclared Sulfites

    Seattle Gourmet Foods Inc. is recalling FungusAmongUs Shiitake Organic Mushrooms due to undeclared sulfites detected by the Florida Department of Agriculture.

    Product
    FungusAmongUs Shiitake Organic Mushrooms are dried mushrooms. Packaged in a clear cellophane bag, net Weight 1 ounce. UPC 7 19870 60023 3 for individual 1 ounce bags UPC 50719870600016 for Master caddy that holds 8 packages of 1 ounce bags The label is read in parts: "***O
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1851-2019·2019-09-18

    Macleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency

    Macleods Pharma USA is recalling Pramipexole Dihydrochloride Tablets 0.125 mg because stability studies showed the drug was subpotent.

    Product
    PRAMIPEXOLE DIHYDROCHLORIDE — PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2144-2019·2019-09-18

    Calcium Supplement Recalled for Lacking Declared Vitamin D Content

    Jivan Shakti Inc. is recalling 790 bottles of Dr. Naram's Rasayana D Tablet because FDA testing found no Vitamin D in the product.

    Product
    Plastic Bottles labeled with: "Ancient Youth Secret - Since 500 B.C., DR. NARAM'S RASAYANA D TABLET, Calcium Supplement with Vitamin D*, Dietary Supplement, 60 Tablets, FOR EXPORT ONLY, Imported & Distributed by: Jivan Shakti INC, 933 South Street, Peekskill, NY 10566, Manufactur
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Food)·F-2148-2019·2019-09-18

    Chicken of the Sea Salmon Pouches Recalled for Microbial Spoilage

    Tri-Union Frozen Products is recalling specific Chicken of the Sea salmon pouches due to microbial activity causing bloating. The product was distributed in four states.

    Product
    Lemon Chive Chicken of the Sea Wild-Caught Pink Salmon Skinless and Boneless, 2.5 oz (70 g) pouch: Shelf Stable UPC 0 48000 01179 4 and 0 480000 11817 7 individual pouch; UPC 1 00 48000 01179 1 - Case Chicken of the Sea International El Segundo, CA Product of Thail
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1855-2019·2019-09-18

    Compounded Acetyl-L-Cysteine Eye Drops Recalled for Processing Control Issues

    Compounded Solutions in Pharmacy is recalling 5% Acetyl-L-Cysteine Ophthalmic Solutions due to a lack of processing controls. The product was dispensed to patients in 5ml and 10ml dropper bottles.

    Product
    5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2150-2019·2019-09-18

    Ruiz Food Products Recalls El Monterey Bean and Cheese Burritos

    Ruiz Food Products is recalling El Monterey XXL Bean and Cheese Burritos due to two complaints of foreign objects in the frozen product.

    Product
    El Monterey XXL Bean and Cheese Burrito; 9.5 oz. frozen burrito in film Microwaveable Case UPC: UPC 1 00 71007 06217 6; Sell unit UPC: 0 71007 06217 9
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2152-2019·2019-09-18

    Stonyfield Kids Strawberry Beet Berry Tubes Recalled for Misbranding

    Stonyfield Farm is recalling 4,064 cartons of Kids Strawberry Beet Berry Tubes because the outer carton labeling does not match the product.

    Product
    Stonyfield Kids Strawberry Beet Berry Tubes, 8 count-2oz each; 453g/package; Keep Refrigerated
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2445-2019·2019-09-11

    Roche Tina-Quant Myoglobin Gen. 2 Assay Recalled for QC Imprecision

    Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific analyzers.

    Product
    The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2019·2019-09-11

    Boston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs

    Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.

    Product
    AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2437-2019·2019-09-11

    Heidelberg SPECTRALIS Ophthalmic Imaging Device Recalled for Data Display Error

    Heidelberg Engineering is recalling 29 SPECTRALIS ophthalmic imaging devices because a software configuration error may cause incorrect display of patient master data.

    Product
    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2019·2019-09-11

    Haag-Streit Recalls HS Hi-R NEO 900A Operating Microscopes Due to Software Error

    Haag-Streit USA Inc is recalling HS Hi-R NEO 900A operating microscopes and specific floor stands due to a software error in the central control unit.

    Product
    HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2448-2019·2019-09-11

    LeMaitre Aortic Occlusion Catheter Recalled for Incorrect Size Labeling

    LeMaitre Vascular is recalling 62 units of Aortic Occlusion Catheters because the packaging lists the incorrect device size.

    Product
    The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall th
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2105-2019·2019-09-11

    Vitony Bakery Cheese-Guava Pudding Cake Recalled for Undeclared Dyes

    Vitony Bakery is recalling 2,354 units of Cheese-Guava Pudding Cake because the product fails to declare FD&C Yellow #5 and FD&C Yellow #6.

    Product
    Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2450-2019·2019-09-11

    SonarMed AirWave Monitor Recalled Due to Potential Error Codes

    SonarMed Inc is recalling 16 AirWave Monitor units because two error codes may render the devices inoperable.

    Product
    SonarMed AirWave Monitor, Model Number M0001
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2441-2019·2019-09-11

    Fujifilm FDR Go Plus X-ray System Recalled for Software Glitch

    Fujifilm is recalling 174 FDR Go Plus mobile X-ray systems because a graphics driver issue may cause the device to display a Blue Screen of Death.

    Product
    Fujifilm FDR Go Plus mobile X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2447-2019·2019-09-11

    Karl Storz Flexible Intubation Fiberscopes Recalled for Manufacturing Defect

    Karl Storz Endoscopy is recalling 14 Flexible Intubation Fiberscopes because they were improperly manufactured with a double port luer instead of a single port luer.

    Product
    Flexible Intubation Fiberscope, Model # 11301AB1
    Category
    Medical Device
    Distribution
    9 states