Import Alert 99-49
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 99-49
Published Date: 08/14/2025
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Devices Without a Unique Device Identifier and/or Matching GUDID Record
Reason for Alert:
The label and package of every medical device must bear a Unique Device Identifier (UDI) that meets the requirements of 21 CFR part 801 subpart B and part 830 when required by 21 CFR 801.20. Additionally, under 21 CFR 830.300(a) and 830.320(b), for each version or model required to bear a UDI, the labeler must submit the information required by 21 CFR part 830 subpart E to FDA's Global Unique Device Identification Database (GUDID).
Devices listed on the Red List of this alert lack a required label and/or package that contains a UDI and/or lack a required GUDID record in the AccessGUDID database (https://accessgudid.nlm.nih.gov/).
Devices listed on the Red List of this alert lack a required label and/or package that contains a UDI and/or lack a required GUDID record in the AccessGUDID database (https://accessgudid.nlm.nih.gov/).
Guidance:
Divisions may detain, without physical examination, shipments of the products identified on the Red List of this alert.
Recommendations for addition to Detention Without Physical Examination (DWPE) should be forwarded to the Division of Import Operations (DIO). Please include any relevant labeling, package inserts, user manuals, photographic evidence, website information, entry documents, and AccessGUDID records or similar information. The following types of devices should not be included:
a. A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
b. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.
c. Custom devices.
d. Investigational devices.
e. Any device otherwise excepted from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.30 or 801.128(f)(2).
f. Any class I device considered a consumer health product which bears a Universal Product Code. Consumer health product is defined in the Guidance for Industry and Food and Drug Administration Staff "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices."
g. Any device which has been granted an exception from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).
h. Any device which has been granted an alternative to the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55 and meets the requirements of the granted alternative. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).
DIO will coordinate a review of all recommendations with FDA's Center for Device and Radiological Health (CDRH) Imports and Registration & Listing Team (IRLT).
For information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning."
For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic
RELEASE OF ARTICLES SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION UNDER THIS IMPORT ALERT:
In order to secure release of an individual shipment that is subject to detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party should provide all relevant information supporting their request for release to FDA.
Information should be submitted to the FDA Division Compliance Office indicated in the 'Notice of FDA Action' notice of detention. Relevant information should pertain to the nature of the original violation and may include evidence such as revised labeling.
REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION (REMOVE FROM RED LIST:
In order to remove a firm's product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to:
Importalerts2@fda.hhs.gov
DIO may coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.
For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via the CDRH Import Mailbox email address: cdrhimport@fda.hhs.gov
Recommendations for addition to Detention Without Physical Examination (DWPE) should be forwarded to the Division of Import Operations (DIO). Please include any relevant labeling, package inserts, user manuals, photographic evidence, website information, entry documents, and AccessGUDID records or similar information. The following types of devices should not be included:
a. A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
b. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.
c. Custom devices.
d. Investigational devices.
e. Any device otherwise excepted from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.30 or 801.128(f)(2).
f. Any class I device considered a consumer health product which bears a Universal Product Code. Consumer health product is defined in the Guidance for Industry and Food and Drug Administration Staff "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices."
g. Any device which has been granted an exception from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).
h. Any device which has been granted an alternative to the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55 and meets the requirements of the granted alternative. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).
DIO will coordinate a review of all recommendations with FDA's Center for Device and Radiological Health (CDRH) Imports and Registration & Listing Team (IRLT).
For information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning."
For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic
RELEASE OF ARTICLES SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION UNDER THIS IMPORT ALERT:
In order to secure release of an individual shipment that is subject to detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party should provide all relevant information supporting their request for release to FDA.
Information should be submitted to the FDA Division Compliance Office indicated in the 'Notice of FDA Action' notice of detention. Relevant information should pertain to the nature of the original violation and may include evidence such as revised labeling.
REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION (REMOVE FROM RED LIST:
In order to remove a firm's product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to:
Importalerts2@fda.hhs.gov
DIO may coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.
Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.
For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via the CDRH Import Mailbox email address: cdrhimport@fda.hhs.gov
Product Description:
Medical Devices
Charge:
The article is a device that appears to be misbranded because its label or device package fails to bear a unique device identifier that meets the requirements of 21 CFR 801 subpart B and 21 CFR part 830, when required by 21 CFR 801.20. [Misbranding, Section 502(c)]
OASIS charge code: UDI LABEL
AND/OR
The article is a device that appears to be misbranded because there was a failure or refusal to electronically submit information required by 21 CFR part 830 subpart E, when required by 21 CFR 830.300(a) and 830.320(b). [Misbranding, Section 502(t)(2)]
OASIS charge code: GUDID
OASIS charge code: UDI LABEL
AND/OR
The article is a device that appears to be misbranded because there was a failure or refusal to electronically submit information required by 21 CFR part 830 subpart E, when required by 21 CFR 830.300(a) and 830.320(b). [Misbranding, Section 502(t)(2)]
OASIS charge code: GUDID
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
Guangdong Kingfa Sci. & Tech. Co., Ltd.
Date Published : 11/21/2024
Qingcheng District , 28 Delong Avenue; Shijiao Town
, Qingyuan,
Guangdong CHINA
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 11/21/2024
Desc: BEASTEK NITRILE GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 11/21/2024
Desc: BEASTEK NITRILE GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 11/21/2024
Desc: BEASTEK NITRILE GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
80 O - - PJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs
Date Published: 11/21/2024
Desc: BEASTEK NITRILE GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
80 Q - - DO Fentanyl and other opioid protection glove
Date Published: 11/21/2024
Desc: BEASTEK NITRILE GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
HUAGUANG MEDICAL PRODUCTS CO.,LTD.
Date Published : 01/16/2025
Yinsha Wan Industrial Park,High-tech Industrial Zone of Hukou County
, Jiujiang,
Jiangxi CHINA
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 01/16/2025
Desc: MCKESSON NITRILE EXAM GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 01/16/2025
Desc: MCKESSON NITRILE EXAM GLOVES
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Date Published : 04/03/2025
Shounan Street Room 903, 666 , Taikang Middle Rd; Yinzhou
, Ningbo,
Zhejiang CHINA
89 I - - TI Wheelchair, Powered
Date Published: 04/03/2025
Desc: TRAVEL BUGGY AEROLUX POWERED ELECTRIC WHEELCHAIR
Notes: Misbranding Section 502(c); Misbranding Section 502(t)(2)
Shen Zhen As Tec Technology Co Ltd
Date Published : 07/29/2024
808 XinBaoYi Industrial Bld, Houting Village , Beiting Road, Shajing
, Shenzhen,
Guangdong CHINA
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 10/10/2024
Desc: Nursal TENS Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 10/10/2024
Desc: Tenker Mini Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 10/10/2024
Desc: Auvon TENS device Model AS8012
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 10/10/2024
Desc: AVCOO TENS and Powered Muscle Stimulator Model AS9020
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Date Published: 07/29/2024
Desc: TENS and Powered Muscle Stimulator
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/10/2024
Desc: Auvon TENS device Model AS8012
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/10/2024
Desc: Tenker Mini Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/10/2024
Desc: Nursal TENS Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 I - - SA Massager, Therapeutic, Electric
Date Published: 10/10/2024
Desc: AVCOO TENS and Powered Muscle Stimulator Model AS9020
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 10/10/2024
Desc: AVCOO TENS and Powered Muscle Stimulator Model AS9020
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 10/10/2024
Desc: Tenker Mini Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 07/29/2024
Desc: TENS and Powered Muscle Stimulator
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 10/10/2024
Desc: Auvon TENS device Model AS8012
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 10/10/2024
Desc: Nursal TENS Massager Model AS1080
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
Wuhan Lotuxs Technology Co., Ltd.
Date Published : 08/29/2024
5F, E2 BUILDING, NO.999 GAOXIN AVENUE, , FUTURE CITY, , EAST LAKE HIGH-TECH DEVELOPMENT ZONE
, Wuhan,
Hubei CHINA
79 O - - HT Light based over-the-counter hair removal
Date Published: 08/29/2024
Desc: CURRENTBODY SKIN LASER HAIR REMOVAL DEVICE
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 08/29/2024
Desc: CURRENTBODY SKIN LASER HAIR REMOVAL DEVICE
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
KOREA (THE REPUBLIC OF)
MEDITIME CO., LTD
Date Published : 03/26/2024
# 605 Medical Complex , 200 Gieopdosi Road, Jieong Myeon
, Wonju,
Gangwon KOREA (THE REPUBLIC OF)
79 N - - EW Suture, Surgical, Absorbable, Polydioxanone
Date Published: 03/26/2024
Desc: VIOLA THREADS PDO COGLYFT-MOLDING 19G 70MM USP 0 / 140MM
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
79 N - - EW Suture, Surgical, Absorbable, Polydioxanone
Date Published: 03/26/2024
Desc: VIOLA THREADS PDO-COBRA COGLYFT 19G 100MM USP 0 / 200MM
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)
79 N - - EW Suture, Surgical, Absorbable, Polydioxanone
Date Published: 03/26/2024
Desc: VIOLA THREADS PDO-MULTI 23G 50MM USP 6-0 / 70MM
Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)