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.

4026–4050 of 21589

  • ModerateFDA (Devices)·Z-0391-2023·2022-12-14

    Surgical Bipolar Forceps Recalled for Incomplete Operating Instructions

    Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning procedures.

    Product
    Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2023·2022-12-14

    CareFusion Bipolar Surgical Forceps Recalled for Incomplete Instructions

    CareFusion bipolar surgical forceps are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.

    Product
    CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2023·2022-12-14

    Carefusion Bipolar Surgical Forceps Recalled for Missing Instructions

    Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface and maintenance procedures.

    Product
    Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Instructions for Use

    Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.

    Product
    Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

    Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on power supply interface and cleaning and maintenance procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Missing Instruction Manual Content

    CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.

    Product
    CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·23063·2022-12-08

    Life is Good Darkest Blue Fleece Sweatshirts and Shorts Recall

    The Life is Good Company is recalling approximately 750 Fall 2022 Darkest Blue fleece sweatshirts and men's shorts that fail to meet federal flammability standards for clothing textiles, posing a risk of burn injuries.

    Product
    Fall 2022 Darkest Blue Fleece Women's Sweatshirts and Men's Shorts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateNHTSA·22V901000·2022-12-07

    Audi Recalls 2023 S3, RS3, and A3 for Missing Weight Label

    Volkswagen Group of America is recalling 2023 Audi S3, RS3, and A3 vehicles because the B-pillar safety label is missing weight capacity information.

    Product
    AUDI — AUDI S3, RS 3, A3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2023·2022-12-07

    BCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error

    Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.

    Product
    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0349-2023·2022-12-07

    Hemoglobin A1c Control Material Produces Incorrect Test Results

    A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.

    Product
    A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0073-2023·2022-12-07

    Allergy Relief D tablets recalled for failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.

    Product
    Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2023·2022-12-07

    Surgical Injection Tray Recalled Due to Adhesive Liner Defect

    Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.

    Product
    Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0325-2023·2022-12-07

    3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect

    3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.

    Product
    Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0350-2023·2022-12-07

    Medical diagnostic control kit recalled for out-of-range quality control results

    Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.

    Product
    Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0353-2023·2022-12-07

    Laboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling

    Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.

    Product
    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0074-2023·2022-12-07

    Acella Recalls Sodium Sulfacetamide Cleansing Pads for Subpotency

    Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.

    Product
    Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0179-2023·2022-12-07

    Coolhaus Dairy Free Frozen Dessert Recalled for Coliform Detection

    Coolhaus Dairy Free Cookie Dough Lyfe frozen dessert sandwiches recalled due to coliform detected in lab samples. Product distributed to select retailers in Texas, Maryland, Colorado, and California.

    Product
    Coolhaus Dairy Free Cookie Dough Lyfe Frozen Dessert Sandwich 3 pk units - 8.75 oz (2.9 oz./unit) UPC: 8 5000988328 5 Distributed by Coolhaus 8688 Washington Blvd. Culver City, CA 90232
    Category
    Food
    Distribution
    4 states
  • ModerateCPSC·23061·2022-12-01

    Summit Treestands Recalls Viper Level PRO SD Climbing Treestands for Fall Hazard

    Summit Treestands LLC is recalling about 2,555 Viper Level PRO SD climbing treestands because the tree cable can dislodge from the cable assembly, creating a fall hazard. No injuries have been reported.

    Product
    Viper Level PRO SD Treestands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23060·2022-12-01

    Target Recalls Cloud Island 4-Piece Plush Toy Sets for Choking Hazard

    Target is recalling Cloud Island 4-Piece Plush Toy Sets because the tires on the toy vehicles can detach, posing a choking hazard to children. The firm has received four reports of tires detaching but no injuries have been reported.

    Product
    Cloud Island 4-Piece Plush Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2023·2022-11-30

    Surgical Convenience Kits Containing Recalled 3M Surgical Drapes

    Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.

    Product
    ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0305-2023·2022-11-30

    Surgical Convenience Kits Recalled by ROi CPS Due to Included 3M Surgical Drapes

    ROi CPS LLC is recalling 456 surgical convenience kits containing 3M surgical drapes that were subject to a separate recall. The kits were distributed across Louisiana, Missouri, North Carolina, and Florida.

    Product
    ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0286-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Unsafe 3M Surgical Drapes

    ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0315-2023·2022-11-30

    Eye Surgery Kit Recall Due to Defective Surgical Drapes

    ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.

    Product
    regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0297-2023·2022-11-30

    FDA Class II Recall of Surgical Convenience Kits with Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0307-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.

    Product
    regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states