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.

826–850 of 21588

  • ModerateFDA (Devices)·Z-1284-2026·2026-02-11

    Sphincterotome KD-VC433Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1272-2026·2026-02-11

    Sphincterotome KD-V411M-0720 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2026·2026-02-11

    Sphincterotome KD-V411M-3020 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1276-2026·2026-02-11

    Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0445-2026·2026-02-11

    Hot everything sauce recalled over undeclared quinine in the product

    Prima Foods International is recalling BarbaCuban 455 Everything Sauce (Hot) because quinine in the product is not declared on the label.

    Product
    BarbaCuban 455 Everything Sauce (Hot), Net Wt 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00083 0
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1309-2026·2026-02-11

    Mobile hoists recalled after a lifting bar mounting bolt broke

    ETAC A/S is recalling 71 units of Molift Mover 300 mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.

    Product
    Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2026·2026-02-11

    Prismaflex TPE2000 sets recalled over a deaeration chamber that may dislodge

    Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.

    Product
    PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2026·2026-02-11

    Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step

    Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2026·2026-02-11

    Sphincterotome KD-VC411Q-0320 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1310-2026·2026-02-11

    Hoist sling bars recalled after a lifting bar mounting bolt broke

    ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.

    Product
    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1300-2026·2026-02-11

    Bubble sensors recalled over connecting cables that can be damaged

    Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.

    Product
    Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2026·2026-02-11

    Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1278-2026·2026-02-11

    Distal wire guided sphincterotomes recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2026·2026-02-11

    Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step

    Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1176-2026·2026-02-04

    Alphenix INFX-8000C systems recalled over ceiling suspension screws that loosen

    Canon Medical Systems is recalling 172 units of the Alphenix INFX-8000C because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.

    Product
    Alphenix INFX-8000C, interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0419-2026·2026-02-04

    Decaf coffee pods recalled because they might contain caffeine

    Keurig Dr Pepper is recalling 960 cartons of McCafe Premium Roast Decaf Coffee K-Cup Pods because the product is labeled as decaf but might contain caffeine.

    Product
    McCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keurig Green Mountain, Inc. Burlington, MA 01803 U.S.A.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1195-2026·2026-02-04

    Central line dressing change kits recalled over cracking adhesive tubing

    Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

    Product
    Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·26V065000·2026-02-04

    Ember travel trailer certification labels may list incorrect weight information

    Ember is recalling certain 2026 E-Series and Overland Series travel trailers because the Federal Certification Label may list incorrect unloaded vehicle weight and cargo carrying capacity information.

    Product
    EMBER — EMBER E-SERIES, OVERLAND SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0428-2026·2026-02-04

    Airway and neuro procedure kits recalled over cracking adhesive tubing

    Medline is recalling 857 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

    Product
    Black Bean Bonanza Tamales with Black Beans NO DAIRY Ingredients: Organic Corn Flour Masa, Black Beans, Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarb
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1218-2026·2026-02-04

    LimFlow Vector devices recalled over an incorrect expiration date

    LimFlow, Inc. is recalling 33 units of the LimFlow Vector, model VT-US-23, over an incorrect expiration date.

    Product
    Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2026·2026-02-04

    Bone graft recalled over an incorrect expiration date on the label

    Cerapedics is recalling 237 units of PearMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc, over an incorrect expiration date.

    Product
    PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1198-2026·2026-02-04

    Circumcision packs recalled over MASTISOL adhesive tubing that can crack

    Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

    Product
    Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1201-2026·2026-02-04

    Tourniquet systems recalled over screens that may freeze in non-English settings

    Zimmer Surgical is recalling 206 A.T.S. 5000TS Tourniquet Systems because the user interface may freeze or become unresponsive to touch in certain non-English language settings.

    Product
    Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Co
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1180-2026·2026-02-04

    Pacemaker and venous access packs recalled over cracking adhesive tubing

    Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

    Product
    Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
    Category
    Medical Device
    Distribution
    Distributed nationwide