The Recall Desk

Manufacturer

Busse Hospital Disposables, Inc.

63 recalls in our database name Busse Hospital Disposables, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
63
Critical
0
Severe
3
Most recent
2024-01-10

Of the 63 recalls from Busse Hospital Disposables, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 63

  • HighFDA (Devices)·Z-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2022·2022-06-08

    FDA Recalls Pellet Insertion Trays Due to Validation Method Uncertainty

    Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B9743
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2022·2022-06-08

    I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.

    Product
    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Validation Uncertainty

    Busse Convenience kits with swab and swabstick drug products are being recalled because the validation of the test methods used during manufacturing is uncertain.

    Product
    "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1193-2022·2022-06-08

    Busse Convenience Kit Swab Products Recalled for Test Method Validation Issues

    Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.

    Product
    SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1195-2022·2022-06-08

    Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1184-2022·2022-06-08

    Pellet Insertion Tray Recall for Uncertain Manufacturing Test Validation

    Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.

    Product
    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2022·2022-06-08

    Procedural Accessory Kit Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Procedural Accessory Kit Catalog Number: 9665R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2022·2022-06-08

    Universal Nerve Block Tray swab products recalled for manufacturing test validation concerns

    Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.

    Product
    Universal Nerve Block Tray Catalog Number: 9779
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2022·2022-06-08

    FDA Recalls Swab Products for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.

    Product
    SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2022·2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.

    Product
    Epidural Tray Catalog 1307
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1185-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled Due to Manufacturing Validation Defects

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.

    Product
    4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2022·2022-06-08

    Busse swab and swabstick products recalled for validation uncertainty

    Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B1144
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2022·2022-06-08

    Stereo Breast Biopsy Tray Recalled for Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.

    Product
    Stereo Breast Biopsy Tray Catalog Number: 2383R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2022·2022-06-08

    Procedure Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.

    Product
    Procedure Tray Catalog 1065
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1173-2022·2022-06-08

    Pump Refill Kit Recalled Over Uncertain Manufacturing Test Method Validation

    Busse Hospital Disposables is recalling Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.

    Product
    Pump Refill Kit Catalog Number: 7347R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1182-2022·2022-06-08

    Busse Convenience Kits Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2022·2022-06-08

    Cervical Tray Catalog 1089 Recalled for Manufacturing Test Method Validation

    Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Cervical Tray Catalog 1089
    Category
    Medical Device
    Distribution
    Distributed nationwide