CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Equipment and table drapes: Ecolab Banded Bag recalled
Microtek Medical is recalling Equipment and table drapes: Ecolab Banded Bag with Rubberband and Tape, distributed nationwide in the US. The recall was initiated on 23 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2250-2023
- FDA event ID
- 92577
- Recalling firm
- Microtek Medical, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2023
- FDA classified
- 28 Jul 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 23 Jun 2023 | Recall initiated by company | |
| 28 Jul 2023 | Classified by FDA | +35 days |
| 9 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain lots of the products have a Naphthalene odor.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
Certain lots of the products have a Naphthalene odor.
Which lots are affected?
(1) Model 63620RT - Lot number 220301F, exp 3/3/2027; UDI-DI 00748426129386; (2) Model 60040S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129348; (3) Model 60050S - Lot number 220305F, exp 3/5/2027; UDI-DI 00748426129355; (4) Model 890017 - Lot numbers 220110F, exp. 1/10/2027; 220108F, exp 1/8/2027; 220102F, exp 1/2/2027; and 211231F, exp 12/31/2026; UDI-DI 00748426063673; and (5) Model 4951N - Lot numbers 220110F, exp 1/10/2027; and 220109F, exp 1/9/2027; UDI-DI 00748426126767.
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Equipment and table drapes and Surgical Room Turnover recalled | Microtek Medical | Other | Nationwide |
More recalls from Microtek Medical
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Microtek Patient Drape Ecolab AP6MMN Patient Drape Adapter Plug Kit recalled | Microtek Medical | Sterility | 20 states |
| Device | CLASS II | Transfer Device recalled by Microtek Medical | Microtek Medical | Sterility | Nationwide |
| Device | CLASS II | C-Flow Bag Decanter recalled by Microtek Medical | Microtek Medical | Sterility | Nationwide |
| Device | CLASS II | Bottle Decanter recalled by Microtek Medical | Microtek Medical | Sterility | Nationwide |
| Device | CLASS II | Equipment and table drapes and Surgical Room Turnover recalled | Microtek Medical | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |