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.

2001–2025 of 3531

  • 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
  • ModerateFDA (Devices)·Z-0316-2023·2022-11-30

    Eye Surgery Convenience Kits Recalled for Defective Surgical Drapes

    Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.

    Product
    regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0281-2023·2022-11-30

    Medical device recall: VS3 Iridium infrared fluorescence microscope

    Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.

    Product
    VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0310-2023·2022-11-30

    Surgical Convenience Kits Recalled for Included 3M Surgical Drapes

    ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.

    Product
    regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric 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-0296-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Included 3M Drape Components

    Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.

    Product
    regard HAND PACK, OR00594K, Item Number 800243011; ortho 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
  • ModerateFDA (Devices)·Z-0287-2023·2022-11-30

    Surgical convenience kits recalled for containing 3M surgical drapes

    ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.

    Product
    regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0284-2023·2022-11-30

    Surgical convenience kits recalled for containing recalled 3M drapes

    Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.

    Product
    regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0289-2023·2022-11-30

    Surgical convenience kits recalled due to included 3M surgical drapes

    Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2023·2022-11-30

    Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes

    ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.

    Product
    regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0295-2023·2022-11-30

    Recall of Surgical Convenience Kits Containing Recalled 3M Drapes

    ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE PACK,NU00395J, Item Number 800241010; ortho 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-0303-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.

    Product
    ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • 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 (Drugs)·D-0068-2023·2022-11-30

    Pantoprazole Sodium Oral Suspension Recalled for Discoloration

    Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2023·2022-11-30

    MicroScan autoSCAN-4 Instrument Recall Due to Incorrect Diffuser Plate

    Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.

    Product
    MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled drape components

    Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).

    Product
    regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0313-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective Component Drapes

    ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.

    Product
    regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0299-2023·2022-11-30

    Surgical convenience kits containing recalled 3M surgical drapes

    ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.

    Product
    regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0317-2023·2022-11-30

    Surgical Urology Kits Recalled Due to Defective 3M Drapes

    ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.

    Product
    regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-0165-2023·2022-11-23

    Similac Water bottles recalled for compromised seal integrity

    Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.

    Product
    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    1 state