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.

1251–1275 of 21710

  • ModerateFDA (Devices)·Z-0937-2026·2025-12-24

    Spinal navigation guide recalled for naming an incompatible toolcard system

    SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-0237-2026·2025-12-24

    Cisatracurium 200 mg vials recalled after subpotent stability assay results

    Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.

    Product
    CISATRACURIUM BESYLATE — CISATRACURIUM BESYLATE (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0228-2026·2025-12-24

    Xylocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 18,789 cartons of 2% Xylocaine Dental with Epinephrine over a defective container with cracked or broken cartridges.

    Product
    2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2026·2025-12-24

    Polocaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 5,825 units of 3% Polocaine Dental mepivacaine injection over a defective container with cracked or broken cartridges.

    Product
    POLOCAINE — POLOCAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0239-2026·2025-12-24

    Ondansetron blister packs recalled because tablets are falling out

    Preferred Pharmaceuticals is recalling 575 blister packs of Ondansetron ODT Tablets, 4mg, after the manufacturer reported that the blister packs are not fully sealed and tablets are falling out.

    Product
    Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0938-2026·2025-12-24

    Clotting time reagent recalled after lots were made with double preservative

    Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.

    Product
    HemosIL SynthAFax. Partial Thromboplastin Time Tests.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0229-2026·2025-12-24

    Lidocaine and epinephrine dental cartridges recalled over cracked containers

    Novocol Pharmaceutical of Canada is recalling 12,033 cartons of Lidocaine HCl 2% with Epinephrine 1:100,000 injection over a defective container with cracked or broken cartridges.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0231-2026·2025-12-24

    Mepivacaine dental cartridges recalled over cracked and broken containers

    Novocol Pharmaceutical of Canada is recalling 5,520 cartons of Mepivacaine HCl 3% injection over a defective container with cracked or broken cartridges.

    Product
    MEPIVACAINE — MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·25V912000·2025-12-23

    2026 Nissan Rogue Vehicles with Incorrect Spare Tire Assembly

    Nissan is recalling 2026 Rogue vehicles with an incorrect-size spare tire that does not match the tire placard information. This may lead to improper tire inflation and increased crash risk.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0893-2026·2025-12-17

    PTC spacer implants recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 13,317 Pillar SA PTC Spacer System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2026·2025-12-17

    Lanthanum carbonate tablets recalled in a second hardness specification failure

    Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0238-2026·2025-12-17

    Matjes herring recalled over undeclared FD&C Red Number 40

    Kosher First is recalling 283 units of Shloimy's Heimishe Matjes Herring over undeclared FD&C Red #40.

    Product
    Shloimy's Heimishe Matjes Herring packaged in 7oz plastic container
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0897-2026·2025-12-17

    Chemotherapy gowns recalled over an expiration date printed two years late

    Cardinal Health is recalling 251,165 ChemoPlus gowns and sleeves because the packaging shows a five-year shelf life when the product's actual shelf life is three years.

    Product
    ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0894-2026·2025-12-17

    Sacroiliac fusion screws recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 19,431 FIREBIRD SI Fusion System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2026·2025-12-17

    Compounded ophthalmic syringes recalled over an incorrect product formulation

    Fagron Compounding Services is recalling 2,980 syringes of a compounded topical ophthalmic solution over an incorrect product formulation.

    Product
    Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0220-2026·2025-12-17

    Ganirelix acetate injection recalled after failing an impurity specification

    Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.

    Product
    GANIRELIX ACETATE — GANIRELIX ACETATE (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·H-0305-2026·2025-12-17

    Fat free milk recalled because it may contain food-grade cleaning agents

    Prairie Farms Dairy is recalling 3,752 gallons of Prairie Farms Fat Free Milk because the product may contain food-grade cleaning agents.

    Product
    Prairie Farms Fat Free Milk, 1 Gallon (3.78L) plastic jug, UPC 7273023117
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0912-2026·2025-12-17

    Hemodialysis systems recalled because a screw may loosen or fall out

    Nipro Medical is recalling Surdial DX Hemodialysis Systems because a screw may loosen or fall out of the system.

    Product
    Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0907-2026·2025-12-17

    Ureteral stent kits recalled because the stent size may not match the label

    C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 6 Fr x 30 cm, because the actual stent size may not match the product label.

    Product
    BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0219-2026·2025-12-17

    Varenicline tablets recalled after an assay value fell below specification

    Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.

    Product
    VARENICLINE TARTRATE — VARENICLINE TARTRATE (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0889-2026·2025-12-17

    Immunoassay reaction vessels recalled over manufacturing deformities causing instrument errors

    Beckman Coulter is recalling 38,225 Access 2 Reaction Vessels because certain lots may have a small protrusion or hair-like deformity that can cause instrument errors and delay patient results.

    Product
    Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0892-2026·2025-12-17

    Frozen surti undhiu mix recalled after testing positive for Salmonella

    Chetak New York is recalling Deep-brand frozen surti undhiu mix after the product tested positive for Salmonella. The FDA has classified the action as Class I.

    Product
    Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0918-2026·2025-12-17

    Bariatric hospital beds recalled because they are not tested with certain mattresses

    Stryker is recalling 294 MV3 bariatric beds because they and Arise 1000EX mattresses have been sold in close proximity, and the two products have not been tested for compatibility.

    Product
    Stryker MV3 bariatric bed, Part Number 5900000001
    Category
    Medical Device
    Distribution
    Distributed nationwide