Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 208 units of surgical packs for knee and hip replacements 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 208 units of 'REEMPLAZO DE RODILLA Y CADERA' surgical convenient packs. The recall involves 7 lots with code 900-2726. These products are EO sterilized surgical packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using these products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE…
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues
FDA (Devices) · 2016-04-20
- HighCustomed Hip and Knee Replacement Surgical Packs Recalled for Sterilization Issues
FDA (Devices) · 2016-04-20
- HighCustomed Medical Device Recall for Sterilization Validation Deficiencies
FDA (Devices) · 2015-09-09
- SevereCustomed Knee and Hip Replacement Trays Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Shoulder Packs Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- HighCustomed Shoulder Packs Recalled for Sterilization Process Validation Issues
FDA (Devices) · 2016-04-20