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.

1951–1975 of 3531

  • ModerateFDA (Devices)·Z-0661-2023·2022-12-21

    FDA Recalls 75 DeRoyal UNIVERSAL PACK Medical Device Kits

    DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available documentation.

    Product
    DeRoyal UNIVERSAL PACK, REF 89-9558.03
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0624-2023·2022-12-21

    Surgical Kit Recall: DeRoyal Shoulder Arthroscopy Pack Class II

    DeRoyal Industries initiated a Class II recall of 100 shoulder arthroscopy surgical kits distributed across 23 U.S. states. The specific defect has not been publicly disclosed in FDA records.

    Product
    DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0628-2023·2022-12-21

    FDA Class II Medical Device Recall: DeRoyal Extremity Pack Kits

    DeRoyal extremity pack kits are subject to a voluntary FDA Class II recall. Three production lots distributed across 23 states are affected.

    Product
    DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0612-2023·2022-12-21

    Medical Device Recall: DeRoyal Podiatry Pack, Class II

    DeRoyal Industries Inc voluntarily recalled 102 kits of its podiatry pack (Lot 57593741, exp. 1/1/2027). The recall affects 22 US states; the specific reason is not detailed in available source material.

    Product
    DeRoyal PODIATRY PACK, REF 89-8359.13
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0658-2023·2022-12-21

    DeRoyal TOTAL HIP KIT orthopedic prosthetic device recalled

    DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.

    Product
    DeRoyal TOTAL HIP KIT, REF 89-9498.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0682-2023·2022-12-21

    Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack

    A voluntary recall of 56 kits of DeRoyal Shoulder Arthroscopy Packs (Model 89-10240.03, Lot 56465579) was initiated by DeRoyal Industries. The FDA classified this Class II recall, which affected multiple U.S. states.

    Product
    DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0584-2023·2022-12-21

    DeRoyal Laparoscopic Robotic Tray Class II Medical Device Recall

    DeRoyal Industries initiated a voluntary recall of 30 kits of a laparoscopic robotic surgical tray (Model 89-7063.11). The reason for the recall is not specified in available FDA records.

    Product
    DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
    Category
    Medical Device
    Distribution
    0 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
    0 states
  • ModerateFDA (Devices)·Z-0575-2023·2022-12-21

    DeRoyal shoulder procedure packs recalled for defective 3M Steri Drapes

    DeRoyal OPEN SHOULDER PROCEDURE PACK RF kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall. A total of 42 kits are affected.

    Product
    DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0570-2023·2022-12-21

    GEO-MED Podiatry Pack Recalled Due to Previously Recalled Component

    DeRoyal Industries is recalling 184 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states because they contain 3M Health Care Steri Drapes that were previously recalled. The affected kits have specific lot numbers with expirations through February 2025.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
    Category
    Medical Device
    Distribution
    0 states
  • ModerateCPSC·23717·2022-12-15

    Crate and Barrel Thornhill Baby Cribs Recalled for Fall Hazard

    Crate and Barrel is recalling about 280 Thornhill baby cribs because mattress support pins can become loose or not fit properly, causing the mattress to fall. The firm received six reports of the mattress support pins not fitting correctly or falling out, though no injuries have been reported.

    Product
    Thornhill Dark Brown and Natural Baby Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23071·2022-12-15

    Gabby D-Ring Fritz Mirrors Recalled Due to Fall and Laceration Hazards

    Gabriella White LLC (Gabby Home) is recalling approximately 930 D-Ring Fritz wall mirrors because the hanging mechanism can fail, causing the mirror to detach and fall from the wall. No injuries have been reported, but seven detachment incidents have occurred.

    Product
    D-Ring Fritz Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Missing Instruction Manual Content

    CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.

    Product
    CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2023·2022-12-14

    Carefusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.

    Product
    Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0388-2023·2022-12-14

    Bipolar Irrigating Forceps Recall: Missing Power Supply and Maintenance Instructions

    Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.

    Product
    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2023·2022-12-14

    Bipolar Forceps Recall: Missing Instructions for Power Supply and Maintenance

    CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.

    Product
    CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2023·2022-12-14

    Carefusion Bipolar Surgical Forceps Recalled for Missing Instructions

    Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface and maintenance procedures.

    Product
    Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning procedures.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Power Supply and Maintenance Instructions

    Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.

    Product
    Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

    Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on power supply interface and cleaning and maintenance procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Instructions for Use

    Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.

    Product
    Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2023·2022-12-14

    HF Resection Electrodes Recalled for Incompatible Packaged Cable

    Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.

    Product
    HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2023·2022-12-14

    IgA and IgM Immunoturbidimetric Assay Testing Order Carryover Avoidance Update

    Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).

    Product
    IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
    Category
    Medical Device
    Distribution
    Distributed nationwide