Food, drugs, devices › Busse Hospital Disposables, Inc.
Device recall: Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
FDA enforcement event 91079 is a device recall by Busse Hospital Disposables, Inc. of Hauppauge, NY, initiated 21 Oct 2022 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Busse Hospital Disposables, Inc. has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Busse Hospital Disposables, Inc., Hauppauge, NY.
Reason for recall
"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"
Distribution
"TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0325-2023 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | 80 cases | Class II | Ongoing | 7 Dec 2022 |
| Z-0326-2023 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | 40 cases | Class II | Ongoing | 7 Dec 2022 |
Context
Other enforcement events for Busse Hospital Disposables, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Nov 2023 | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | Device | Class I | 3 |
| 22 Feb 2022 | I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822 | Device | Class II | 58 |
All 3 events for Busse Hospital Disposables, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "TX"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.