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.

1151–1175 of 21710

  • ModerateFDA (Devices)·Z-1049-2026·2026-01-21

    Allura Xper FD20/10 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20/10, model 722029, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2026·2026-01-21

    Spinal instrument sets recalled because the rotation tool handle can untread

    Medicrea International is recalling 44 IB3D PL Instruments Sets because, following complaints, the orthopedic rotation tool handle may untread from the shaft.

    Product
    Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2026·2026-01-21

    Carotid anesthesia kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 10 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1056-2026·2026-01-21

    IV start kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 5314 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1061-2026·2026-01-21

    Hydrophilic catheters recalled over an incorrect expiration date on labeling

    Hangzhou Bever Medical Devices is recalling 149,310 BD Ready-to-Use Hydrophilic Catheters, 14 Fr, over a labeling error giving an incorrect expiration date.

    Product
    BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0280-2026·2026-01-21

    PALACOS MV plus G bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS MV+G pro 40 and PALACOS MV+G pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Swan, White Clear Alcohol, 50%, 16oz, 12 count
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0386-2026·2026-01-21

    Strawberry jam recalled over an unapproved colour additive

    Mangalm LLC is recalling Tops Strawberry Jam because it contains an unapproved colour, carmoisine.

    Product
    Tops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1074-2026·2026-01-21

    Allura Xper FD10/10 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 22 units of the Allura Xper FD10/10, model 722027, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10/10; Model Number: 722027;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1062-2026·2026-01-21

    Allura Xper FD10C systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 38 Allura Xper FD10C systems because the drip tray beneath the cooling unit may not have been installed.

    Product
    Product Name: Allura Xper FD10C; Model number: 722001;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1080-2026·2026-01-21

    PALACOS R bone cement recalled because ampoules may not break

    Heraeus Medical is recalling PALACOS R pro 40 and PALACOS R pro 80 bone cement because a combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.

    Product
    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·H-0387-2026·2026-01-21

    Mixed fruit jam recalled over an unapproved colour additive

    Mangalm LLC is recalling Tops Mixed Fruit Jam because it contains an unapproved colour, carmoisine.

    Product
    Tops Mixed Fruit Jam INGREDIENTS: Sugar, Mixed Fruit Pulp 48% (Apple, Pear, Guava, Pineapple, Banana, Mango, Grapes, Papaya), Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium metabisulphite - INS…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1072-2026·2026-01-21

    Allura Xper FD20 OR Table recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20 OR Table, model 722023, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20 OR Table; Model Number: 722023;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2026·2026-01-21

    Allura Xper FD10F systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 12 units of the Allura Xper FD10F, model 722002, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10F; Model Number: 722002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1051-2026·2026-01-21

    Pre-op kits recalled because they contain recalled B. Braun administration sets

    Medline is recalling 32 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1077-2026·2026-01-21

    Allura Xper FD20/20 systems recalled over a missing cooling unit drip tray

    Philips Medical Systems Nederland is recalling 8 units of the Allura Xper FD20/20, model 722038, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20/20; Model Number: 722038;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2026·2026-01-21

    Allura Xper FD10/10, model 722011, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 21 units of the Allura Xper FD10/10, model 722011, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10/10; Model Number: 722011;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0274-2026·2026-01-21

    Admission and admin kits recalled over recalled B. Braun administration sets

    Medline is recalling 1725 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1055-2026·2026-01-21

    IV supply drawers recalled over recalled B. Braun administration sets inside

    Medline is recalling 3045 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1088-2026·2026-01-21

    Robotic and gynaecology kits recalled over leaking suction irrigators inside

    Medline is recalling 12,584 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1059-2026·2026-01-21

    Neuro angio packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 12 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2026·2026-01-21

    Allura Xper FD20 Biplane, model 722013, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 23 units of the Allura Xper FD20 Biplane, model 722013, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD10; Model Number: 722026;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1089-2026·2026-01-21

    Hysterectomy procedure kits recalled over leaking suction irrigators inside

    Medline is recalling 1457 units of procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1053-2026·2026-01-21

    Donor nephrectomy accessory kits recalled over recalled B. Braun sets

    Medline is recalling 33 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2026·2026-01-21

    Allura Xper FD20, model 722028, recalled over a missing drip tray

    Philips Medical Systems Nederland is recalling 2 Allura Xper FD20 systems because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20; Model Number: 722028;
    Category
    Medical Device
    Distribution
    Distributed nationwide