thejoe Busse Hospital Disposables, Inc.

Busse Hospital Disposables, Inc.: 63 FDA recall reports

Every medical device recall the FDA has published for Busse Hospital Disposables, Inc.. The fault, and how the agency graded it.

63Reports

3Class I

5Ongoing

2024-01-10Most recent

3 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	60
Class I	3

By year reported

Year	Reports
2022	60
2024	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Class I

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

Z-0594-2024 · Class I · reported 2024-01-10 · Ongoing

Why it was recalled: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Product: Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Where it went: US Nationwide distribution.
How much: 240

Class I

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Z-0593-2024 · Class I · reported 2024-01-10 · Ongoing

Why it was recalled: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Product: Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Where it went: US Nationwide distribution.
How much: 536

Class I

Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE

Z-0592-2024 · Class I · reported 2024-01-10 · Ongoing

Why it was recalled: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Product: Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Where it went: US Nationwide distribution.
How much: 705

Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1

Z-0325-2023 · Class II · reported 2022-12-07 · Ongoing

Why it was recalled: Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Product: Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Where it went: TX
How much: 80 cases

Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

Z-0326-2023 · Class II · reported 2022-12-07 · Ongoing

Why it was recalled: Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Product: Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Where it went: TX
How much: 40 cases

3.2MM Pellet Insertion Tray Catalog Number: B9743

Z-1203-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: 3.2MM Pellet Insertion Tray Catalog Number: B9743
Where it went: Nationwide
How much: 150 units

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

Z-1194-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Where it went: Nationwide
How much: 100 units

Nerve Block Tray Catalog Number: 8415

Z-1158-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Nerve Block Tray Catalog Number: 8415
Where it went: Nationwide
How much: 420 units

Single Shot Epidural Tray Catalog Number: 8417

Z-1159-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Single Shot Epidural Tray Catalog Number: 8417
Where it went: Nationwide
How much: 400 units

SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560

Z-1193-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Where it went: Nationwide
How much: 30 units

SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1

Z-1200-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Where it went: Nationwide
How much: 50 units

Pain Tray Catalog Number: 9883

Z-1164-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Pain Tray Catalog Number: 9883
Where it went: Nationwide
How much: 421 units

Core Biopsy Tray Catalog Number: 8673R4

Z-1176-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Core Biopsy Tray Catalog Number: 8673R4
Where it went: Nationwide
How much: 285 units

SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559

Z-1192-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
Where it went: Nationwide
How much: 30 units

Procedural Accessory Kit Catalog Number: 9665R2

Z-1178-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Procedural Accessory Kit Catalog Number: 9665R2
Where it went: Nationwide
How much: 250 units

Pump Refill Kit Catalog Number: 7347R1

Z-1173-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Pump Refill Kit Catalog Number: 7347R1
Where it went: Nationwide
How much: 40 units

Joint Injection Tray Catalog Number: 8561R1

Z-1175-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Joint Injection Tray Catalog Number: 8561R1
Where it went: Nationwide
How much: 480 units

Lumbar Tray Catalog 1091

Z-1150-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Lumbar Tray Catalog 1091
Where it went: Nationwide
How much: 330 units

Universal Nerve Block Tray Catalog Number: 9818

Z-1162-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Universal Nerve Block Tray Catalog Number: 9818
Where it went: Nationwide
How much: 60 units

Nerve Block Tray Catalog Number: 3764R2

Z-1167-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Nerve Block Tray Catalog Number: 3764R2
Where it went: Nationwide
How much: 250 units

Single Shot Epidural Tray Catalog Number: 6183R1

Z-1169-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Single Shot Epidural Tray Catalog Number: 6183R1
Where it went: Nationwide
How much: 425 units

4.5 MM Pellet Insertion Tray Catalog Number: B8121R1

Z-1199-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Where it went: Nationwide
How much: 99 units

"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351

Z-1180-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Where it went: Nationwide
How much: 120 units

SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1

Z-1182-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Where it went: Nationwide
How much: 120 units

Sterile Epidural Tray Catalog Number: 6259R2

Z-1170-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Sterile Epidural Tray Catalog Number: 6259R2
Where it went: Nationwide
How much: 50 units

Port Tray Catalog 7607

Z-1156-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Port Tray Catalog 7607
Where it went: Nationwide
How much: 576 units

I.V. Start Kit Catalog 8172

Z-1157-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: I.V. Start Kit Catalog 8172
Where it went: Nationwide
How much: 4218 units

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

Z-1184-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Where it went: Nationwide
How much: 90 units

Nerve Block Tray Catalog Number: 9342

Z-1160-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Nerve Block Tray Catalog Number: 9342
Where it went: Nationwide
How much: 64 units

Single Shot Epidural Tray Catalog Number: 6797R2

Z-1172-2022 · Class II · reported 2022-06-08 · Terminated

Why it was recalled: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Product: Single Shot Epidural Tray Catalog Number: 6797R2
Where it went: Nationwide
How much: 40 units

Showing the 30 most recent of 63. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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