Theragenics Brachytherapy Applicator Needles Recalled for Unsealed Pouches
Theragenics is recalling Brachytherapy Applicator Needles because some pouches were not sealed, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the unsealed packaging poses a risk of contamination or loss of sterility for a medical device used in brachytherapy, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Theragenics Corporation is recalling Brachytherapy Applicator Needles (18g x 20cm) because some of the pouches containing the needles were not sealed. The device consists of a wire stylus with a plastic handle, a plastic needle hub, a protective needle sleeve, and a hollow steel needle.
The recall involves 480 packs (5 needles each), which are part of a box of 25 needles containing five single packs and four 5-packs. The affected lot number is 180904-80. The product was distributed nationwide to Florida, California, Alabama, Delaware, North Carolina, Texas, Utah, and Mississippi, as well as internationally to South Africa.
Healthcare providers and consumers should stop using the affected needles and contact Theragenics Corporation for further instructions or a replacement.
The recalled product
- Product
- Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.
- Manufacturer
- Theragenics Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Box part number CPPS-MN-1820
- Multipack part number CPPS-MN-1820-5
- UDI: (01)00813787021515(10)18090480(11)180904(17)220831
- Lot # 180904-80
Distribution
Related recalls
Same hazard · contamination
See all →- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls injeTAK Adjustable Tip Needles for Damaged Packaging
FDA (Devices) · 2023-05-10
- HighArrow International Recalls Echogenic Introducer Needles Due to Packaging Defect
FDA (Devices) · 2018-06-06
- HighTerumo 18G Needles Recalled for Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- ModerateFDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
FDA (Devices) · 2017-08-16
- HighArgon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk
FDA (Devices) · 2017-02-22
- HighTeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
FDA (Devices) · 2020-07-15