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.

3976–4000 of 21589

  • ModerateFDA (Devices)·Z-0674-2023·2022-12-21

    FDA recalls DeRoyal NEURO PACK medical device kits across 23 states

    DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.

    Product
    DeRoyal NEURO PACK, REF 89-10171.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0603-2023·2022-12-21

    DeRoyal EYE TRAY Procedure Packs Recalled Due to 3M Steri Drape Recall

    DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across multiple U.S. states.

    Product
    DeRoyal EYE TRAY PGYBK, REF 89-7978.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0630-2023·2022-12-21

    Medical device recall: DeRoyal cardiac kit Class II

    DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.

    Product
    DeRoyal KIT HEART B PACK, REF 89-9042.08
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0623-2023·2022-12-21

    Medical device eye pack manufactured by DeRoyal Industries recalled

    DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.

    Product
    DeRoyal EYE PACK, REF 89-8756.03
    Category
    Medical Device
    Distribution
    23 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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0636-2023·2022-12-21

    DeRoyal BASIC EYE PACK Medical Device Voluntary Recall

    DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.

    Product
    DeRoyal BASIC EYE PACK, REF 89-9233.08
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0673-2023·2022-12-21

    DeRoyal NEURO PACK medical device recalled by manufacturer across United States

    DeRoyal Industries has voluntarily recalled 162 NEURO PACK neurological medical device kits distributed across 23 U.S. states. The reason for the recall was not disclosed by the manufacturer.

    Product
    DeRoyal NEURO PACK, REF 89-10171.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0604-2023·2022-12-21

    GEO-MED Lower Extremity Procedure Packs Recalled Due to Defective 3M Steri Drapes

    DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United States.

    Product
    GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0681-2023·2022-12-21

    FDA Recalls DeRoyal Pacemaker ICD Pack, Lot 57898501

    DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.

    Product
    DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0679-2023·2022-12-21

    DeRoyal Lumbar Fusion Pack Subject to FDA Class II Recall

    DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.

    Product
    DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0699-2023·2022-12-21

    Medical Device Class II Recall: DeRoyal LAMI/CRANI PACK surgical kits

    DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.

    Product
    DeRoyal LAMI/CRANI PACK, REF 89-10787.01
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0683-2023·2022-12-21

    Medical device recall issued for DeRoyal CRANI PACK across multiple states

    DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.

    Product
    DeRoyal CRANI PACK, REF 89-10242.02
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0678-2023·2022-12-21

    DeRoyal laminectomy surgical instrument kits subject to Class II recall

    DeRoyal Industries is recalling LAMINECTOMY PACK surgical kits (Lot 56388471) distributed in multiple US states. Healthcare facilities with affected kits should verify their inventory and contact the manufacturer for guidance.

    Product
    DeRoyal LAMINECTOMY PACK, REF 89-10209.02
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0622-2023·2022-12-21

    FDA Class II Medical Device Recall: GEO-MED Biopsy Tray

    DeRoyal Industries Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.

    Product
    GEO-MED BIOPSY TRAY, REF 89-8753.01
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0704-2023·2022-12-21

    Medical Device Recall: DeRoyal Surgical Knee Pack Components

    DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.

    Product
    DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0649-2023·2022-12-21

    DeRoyal Endovascular Tracepack Medical Device Recall, FDA Class II

    DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.

    Product
    DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
    Category
    Medical Device
    Distribution
    23 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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0641-2023·2022-12-21

    DeRoyal NEURO PACK medical device recalled voluntarily by manufacturer

    DeRoyal Industries Inc initiated a voluntary recall of 93 kits of the DeRoyal NEURO PACK affecting 23 U.S. states. The recall affects three lot numbers with March 1, 2025 expiration.

    Product
    DeRoyal NEURO PACK, REF 89-9253.07
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0710-2023·2022-12-21

    Surgical Supply Recall: DeRoyal Cataract Pack Class II 440 Kits

    DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the notice.

    Product
    DeRoyal CATARACT PACK, REF 89-8650.10
    Category
    Medical Device
    Distribution
    23 states