Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 2,620 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
Plain-English summary
Customed, Inc. is recalling 2,620 units of Arthroscopy Packs (Product Code 900-620) across 28 lots. The recall was initiated because the company determined that packaging integrity may be compromised on different catalog numbers. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The compromised packaging integrity could result in product contamination or loss of sterility condition, which poses a risk of injury to patients. The recall covers 28 specific lots, including lot numbers 111113132, 111123276, and 112010192, among others.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected Arthroscopy Packs and contact Customed, Inc. for further instructions.
The recalled product
- Product
- ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~…
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 (1)
- Product code 900-620
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 233 products in this recall →Related recalls
Same manufacturer · Customed, Inc
See all →- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
Same hazard · contamination
See all →- SevereSpectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
FDA (Devices) · 2026-10-07
- SevereSpectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
FDA (Devices) · 2026-10-07
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighMedline Recalls Minor Pack Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Arthroscopy Pack Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Arthroscopy Packs Recalled Due to Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Arthroscopy Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Arthroscopy Packs Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Arthroscopy Packs Recalled for Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Arthroscopy Pack Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10