CLASS II Device recall · Reported 18 May 2022 · FDA Enforcement Report
TMJ Arthroscopy Drape, 85''x 96'' recalled by Microtek Medical
Microtek Medical is recalling TMJ Arthroscopy Drape, 85''x 96'', distributed nationwide in the US. The recall was initiated on 8 Apr 2022 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-1071-2022
- FDA event ID
- 89956
- Recalling firm
- Microtek Medical, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2022
- FDA classified
- 12 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Apr 2022 | Recall initiated by company | |
| 12 May 2022 | Classified by FDA | +34 days |
| 18 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Latex content in product was labeled incorrectly as latex free.
Product as listed by the FDA
TMJ Arthroscopy Drape, 85''x 96''
Where it was distributed
Distributed nationwide to CO, PA, and WI.
Questions about this recall
Why was it recalled?
Latex content in product was labeled incorrectly as latex free.
Which lots are affected?
SKU Number 3601; Lot code/Expiration Date: Lot D181232, exp. 05/01/2022; Lot D181982, exp. 07/01/2022; Lot D202232, exp.08/01/2024; Lot D210742, exp. 03/01/2025; Lot D211372, exp. 05/01/2025; Lot D212562, exp. 09/01/2025; Lot D213122, exp. 11/01/2025; and Lot D213402, exp. 12/01/2025. UDI: 50748426008556
Where was it sold?
Distributed nationwide to CO, PA, and WI.
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.
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 Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |