Shippert Medical Technologies Corp.
United StatesFDA applicant, unverified
- Devices
- 595
- FDA recalls
- 15
What Shippert Medical Technologies Corp. makes
Shippert Medical Technologies Corp. manufactures single-use medical wipes and nasal packs for procedural preparation, including alcohol-impregnated instrument wipes and anatomical nasal packs with or without airways. Their portfolio also includes injectable nasal packs, deep-pressure massage devices like the Muscle Wand, and filtration systems such as the TISSU-TRANS and its associated tubing and syringe fill components.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 595 devicesShowing 251-300 of 595
FDA recalls
FDA recall records list 15 recalls initiated by Shippert Medical Technologies Corp., the earliest on 2017-06-01 and the most recent on 2018-02-02. By recorded status: 8 terminated and 7 with another status. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 8
- 2018 7
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 2 Feb 2018 Z-1330-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1331-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1332-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1333-2019 Class II Completed —
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- 2 Feb 2018 Z-1334-2019 Class II Completed —
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- 2 Feb 2018 Z-1335-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1336-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1330-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
2017
- 20 Oct 2017 Z-0170-2018 Class II Terminated Potential breach of sterility of the packaging.
- 1 Jun 2017 Z-3060-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3061-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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Show all 15 recalls
2017
- 1 Jun 2017 Z-3062-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3063-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3064-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3065-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3066-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3062-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.