Manufacturer

Busse Hospital Disposables, Inc.

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

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.

1–25 of 63

SevereFDA (Devices)·Z-0592-2024·2024-01-10
Tracheostomy care kits recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Product
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2024·2024-01-10
Tracheostomy care sets recalled for sterility assurance failure
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
Product
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0593-2024·2024-01-10
Dressing change tray recalled for sterility assurance failure
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Product
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0325-2023·2022-12-07
3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.
Product
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0326-2023·2022-12-07
Surgical Injection Tray Recalled Due to Adhesive Liner Defect
Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.
Product
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Category
Medical Device
Distribution
1 state
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-1158-2022·2022-06-08
Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
Product
Nerve Block Tray Catalog Number: 8415
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2022·2022-06-08
Swab drug products recalled due to inadequate test method validation
Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.
Product
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2022·2022-06-08
Busse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues
Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Product
4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2022·2022-06-08
Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty
Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.
Product
Epidural Tray Catalog 1577
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2022·2022-06-08
Sterile Epidural Tray Recalled Due to Validation Uncertainty
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Product
Sterile Epidural Tray Catalog Number: 6259R2
Category
Medical Device
Distribution
Distributed nationwide
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-1188-2022·2022-06-08
Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
Product
SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
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
HighFDA (Devices)·Z-1171-2022·2022-06-08
Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty
Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.
Product
Nerve Block Tray Catalog Number: 6796R3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1199-2022·2022-06-08
Busse Convenience Kits With Swab Products Recalled for Manufacturing Validation Issues
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are recalled due to uncertainty about manufacturing test method validation.
Product
4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2022·2022-06-08
Convenience Kits With Swab Drug Products Recalled for Test Validation Failure
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Product
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2022·2022-06-08
Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
Product
SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Category
Drug
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-1169-2022·2022-06-08
Epidural Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Product
Single Shot Epidural Tray Catalog Number: 6183R1
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-1172-2022·2022-06-08
Single Shot Epidural Tray recalled due to inadequate test method validation
Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.
Product
Single Shot Epidural Tray Catalog Number: 6797R2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2022·2022-06-08
Swab and Swabstick Drug Products Recalled for Manufacturing Validation Uncertainty
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Product
Joint Injection Tray Catalog Number: 8561R1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1160-2022·2022-06-08
Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.
Product
Nerve Block Tray Catalog Number: 9342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2022·2022-06-08
Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Product
Nerve Block Tray Catalog Number: 3764R2
Category
Drug
Distribution
Distributed nationwide