CLASS II Device recall · Reported 10 Nov 2021 · FDA Enforcement Report
The Medrad Twist & Go Disposable Syringe recalled by Bayer Medical Care
Bayer Medical Care is recalling The Medrad Twist & Go Disposable Syringe with Quick Fill Tube is a syringe made from a, distributed nationwide in the US. The recall was initiated on 14 Sep 2021 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-0199-2022
- FDA event ID
- 88807
- Recalling firm
- Bayer Medical Care, Indianola, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2021
- FDA classified
- 3 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 14 Sep 2021 | Recall initiated by company | |
| 3 Nov 2021 | Classified by FDA | +50 days |
| 10 Nov 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Product as listed by the FDA
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
Questions about this recall
Is The Medrad Twist & Go Disposable Syringe with Quick Fill Tube is a syringe made from a recalled?
Yes. Bayer Medical Care recalled The Medrad Twist & Go Disposable Syringe with Quick Fill Tube is a syringe made from a on 14 Sep 2021. The recall is Class II and its status is Terminated. Recall number Z-0199-2022.
Why was it recalled?
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Which lots are affected?
Batch number: 8415317
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.
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 21 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 Bayer Medical Care
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT recalled | Bayer Medical Care | Other | Nationwide |
| Device | CLASS II | Source Administration Set (SAS) used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | Medrad Stellant Flex Syringe Kits Angiographic Syringe recalled | Bayer Medical Care | Packaging Defects | Nationwide |
| Device | CLASS II | Codan Filter (Codan recalled by Bayer Medical Care | Bayer Medical Care | Particulate Matter | Nationwide |
| Device | CLASS II | Overhead Counterpoise Systems (Ocs), Ocs Conf,Std Ceil Mnt recalled | Bayer Medical Care | Lead & Heavy Metals | OH, TX, WV |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |