Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling ophthalmic surgical 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 specific ophthalmic surgical packs due to a potential compromise in packaging integrity. The recalled items include various surgical instruments, drapes, syringes, and needles packaged in EO sterilized surgical convenient packs. The company identified that the packaging may not be fully intact, which could affect the sterility of the contents.
The recall involves two lots of the product, totaling 60 units. The affected lots are identified by the codes 113099550 and 113109831, under product code 900-357. The distribution of these products was worldwide, including the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and several international locations such as Tortola, Trinidad, the Dominican Republic, Costa Rica, and Mexico.
The primary hazard associated with this recall is the risk of patient injury due to product contamination or the loss of the sterile condition of the surgical instruments. Users of these medical devices should check their inventory for the specific lot numbers listed and contact the manufacturer or their supplier for further instructions on how to handle the affected units.
The recalled product
- Product
- OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC…
- 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 (2)
- Product code 900-357
- 2 lots: 113099550 113109831
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 →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits 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
Similar recalls
- SevereCustomed Ophthalmic Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Ophthalmic Packs Recalled for Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- HighCustomed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- SevereCustomed OB Packs Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed OB Packs Recalled Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Laparotomy Packs Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10