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.

1876–1900 of 3531

  • ModerateFDA (Devices)·Z-0586-2023·2022-12-21

    DeRoyal Cataract Procedure Packs Recalled Due to Affected 3M Steri Drapes

    DeRoyal Industries is recalling 190 cataract procedure packs that contain 3M Health Care Steri Drapes which have been recalled. The affected packs were distributed across 22 US states.

    Product
    DeRoyal CATARACT PACK, REF 89-7135.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0590-2023·2022-12-21

    DeRoyal BASIC NEURO PACK kits recalled due to 3M Steri Drapes recall

    DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.

    Product
    DeRoyal BASIC NEURO PACK, REF 89-7258.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0639-2023·2022-12-21

    DeRoyal Foot Pack Medical Device Class II Recall

    DeRoyal Industries has initiated a voluntary Class II recall of 217 kits of its DeRoyal Foot Pack (REF 89-9252.07). The recall affects multiple U.S. states.

    Product
    DeRoyal FOOT PACK, REF 89-9252.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0714-2023·2022-12-21

    Cataract surgical pack Class II recall issued

    DeRoyal CATARACT PACK surgical kits are subject to a voluntary Class II recall affecting 108 kits across 23 U.S. states. The specific reason for the recall is not provided in available documentation.

    Product
    DeRoyal CATARACT PACK, REF 89-10040.01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0621-2023·2022-12-21

    DeRoyal PORT PACK medical device recalled: lot-specific kits

    DeRoyal Industries Inc is voluntarily recalling 240 kits of the PORT PACK PGYBK medical device distributed across 22 U.S. states. The specific reason for recall is not disclosed in available source material.

    Product
    DeRoyal PORT PACK PGYBK, REF 89-8748.05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0589-2023·2022-12-21

    FDA Class II Recall: DeRoyal Lapinectomy Pack Surgical Kits

    DeRoyal Industries initiated a voluntary recall of 715 Lapinectomy Pack surgical kits (Ref 89-7198.11) distributed to 23 US states. The FDA Class II recall remains ongoing.

    Product
    DeRoyal LAPINECTOMY PACK, REF 89-7198.11
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0620-2023·2022-12-21

    FDA Recalls GEO-MED Podiatry Pack Medical Device Kit

    DeRoyal Industries voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0668-2023·2022-12-21

    DeRoyal Facial Pack Medical Device Under Voluntary FDA Recall

    DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.

    Product
    DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0578-2023·2022-12-21

    Medical device recall: GEO-MED Total Knee Pack surgical kits

    DeRoyal Industries voluntarily recalled 49 kits of the GEO-MED TOTAL KNEE PACK A & B distributed across 23 U.S. states. The specific reason for the recall is not detailed in the FDA notice.

    Product
    GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0605-2023·2022-12-21

    Medical Device Recall: GEO-MED Upper Extremity Pack Kit

    DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.

    Product
    GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0697-2023·2022-12-21

    DeRoyal GU PACK Medical Device Voluntary Recall

    DeRoyal Industries Inc voluntarily recalled 57 kits of the DeRoyal GU PACK medical device. The specific reason for the recall was not provided in the available source documentation.

    Product
    DeRoyal GU PACK, REF 89-10665.03
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0654-2023·2022-12-21

    DeRoyal EMERGENT TRAUMA PACK recall affects 18 kits across 23 states

    DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.

    Product
    DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0687-2023·2022-12-21

    Medical device manufacturer recalls pain trays in 23 US states

    DeRoyal Industries is voluntarily recalling 1,100 kits of pain tray devices distributed across 23 US states. The FDA classified this as a Class II recall.

    Product
    DeRoyal PAIN TRAY, REF 89-10464.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0606-2023·2022-12-21

    FDA Class II recall issued for DeRoyal BASIC EYE PACK medical device

    DeRoyal Industries Inc recalled 45 kits of its BASIC EYE PACK medical device distributed to healthcare facilities across the United States. The FDA classified this as a voluntary Class II recall.

    Product
    DeRoyal BASIC EYE PACK, REF 89-8337.08
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0696-2023·2022-12-21

    FDA Medical Device Recall: DeRoyal GU Pack genitourinary kits

    DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA documentation.

    Product
    DeRoyal GU PACK, REF 89-10665.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0614-2023·2022-12-21

    DeRoyal SPINE PACK procedure kits recalled due to included 3M Steri Drapes

    DeRoyal Industries is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.

    Product
    DeRoyal SPINE PACK, REF 89-8361.09
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0707-2023·2022-12-21

    Medical device recall: DeRoyal TRACECART posterior lumbar fusion kits

    DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.

    Product
    DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0702-2023·2022-12-21

    Medical Device Recall: DeRoyal NEURO SPINE BACK PACK Kit

    DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.

    Product
    DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0637-2023·2022-12-21

    DeRoyal Orthopedic Kit Recalled; Reason Not Specified in Notice

    DeRoyal MAJOR ORTHO PACK kits (Ref 89-9250.07) are being voluntarily recalled. The specific reason is not provided in the FDA notice. Affected lots were distributed across 23 U.S. states.

    Product
    DeRoyal MAJOR ORTHO PACK, REF 89-9250.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0563-2023·2022-12-21

    DeRoyal Extremity Trays Recalled Due to Affected 3M Steri Drapes

    DeRoyal is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are distributed across multiple U.S. states.

    Product
    DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0713-2023·2022-12-21

    DeRoyal cataract pack (Model 89-9241.04) recalled by FDA

    DeRoyal Industries initiated a voluntary recall of 552 units of its CATARACT PACK due to an unspecified defect. The FDA classified this Class II recall on December 15, 2022.

    Product
    DeRoyal CATARACT PACK, REF 89-9241.04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0478-2023·2022-12-21

    CarePoint 60 mL Syringes Recalled Due to Green Substance on Plunger

    Allison Medical recalls CarePoint 60 mL syringes due to green substance found on plungers. While the substance is nontoxic, its potential interaction with medications is unknown.

    Product
    CarePoint 60 mL Syringe Without Needle, REF: 04-7560
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0650-2023·2022-12-21

    Medical Device Shoulder Pack Recall Initiated by Manufacturer

    DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.

    Product
    DeRoyal SHOULDER PACK, REF 89-9449.12
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0665-2023·2022-12-21

    DeRoyal Biopsy Pack Kits Subject to Voluntary Recall

    DeRoyal Industries voluntarily recalled 360 kits of its BIOPSY PACK (Lot 57686568) distributed across 22 U.S. states. The specific reason for the recall is not specified in available FDA documentation.

    Product
    DeRoyal BIOPSY PACK, REF 89-9739.06
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0599-2023·2022-12-21

    DeRoyal BASIC NEURO PACK Medical Device Recall with Unspecified Reason

    DeRoyal Industries is recalling 288 BASIC NEURO PACK medical device kits distributed across 23 U.S. states. The reason for the recall is not specified in available documentation.

    Product
    DeRoyal BASIC NEURO PACK, REF 89-7523.15
    Category
    Medical Device
    Distribution
    0 states