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.

926–950 of 21588

  • ModerateFDA (Devices)·Z-1076-2026·2026-01-21

    Preoperative kits recalled over recalled B. Braun administration sets inside

    Medline is recalling 11173 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
    Allura Xper FD20/10; Model Number: 722029;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2026·2026-01-21

    Open heart kits recalled because they contain recalled B. Braun administration sets

    Medline is recalling 633 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) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752
    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; 4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1086-2026·2026-01-21

    Laparoscopy kits recalled over suction irrigators that can leak during use

    Medline is recalling 41,432 laparoscopy 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) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 224)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0402-2026·2026-01-21

    Mandible and ear procedure packs recalled over recalled B. Braun sets

    Medline is recalling 96 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
    Atwater's, Holiday Cookie Tin, 19.65 ounces, Round metal tin with a window lid
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1054-2026·2026-01-21

    Facial procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 16 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: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
    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 (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
  • 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-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 (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 Flavouring
    Category
    Food
    Distribution
    1 state
  • 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 (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-1017-2026·2026-01-21

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

    Philips Medical Systems Nederland is recalling 79 units of the Allura Xper FD20, model 722012, because the drip tray beneath the cooling unit may not have been installed.

    Product
    VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
    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 fo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1091-2026·2026-01-21

    Azurion systems recalled over six identified software issues

    Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.

    Product
    Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2026·2026-01-21

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

    Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.

    Product
    Allura Xper FD20 Biplane; Model Number: 722008;
    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-1060-2026·2026-01-21

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

    Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, 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: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE
    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 LAVH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2026·2026-01-21

    Surgical procedure packs recalled over recalled B. Braun administration sets inside

    Medline is recalling 338 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
    Allura Xper FD20; Model Number: 722012;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2026·2026-01-21

    Fluocinolone topical solution recalled after failing an impurity specification

    Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution 0.01% after an out of specification result for a known impurity.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide