Archive
1,186 recalls were announced in September 2015.
Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.
Which agencies issued them
Customed, Inc. is recalling 55 plastic surgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling surgical gowns in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 3,550 Tracheotomy Care Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 155 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 216 units of Cool Impervious XLGE Breathable surgical gowns due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Angiodrape Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling Pery-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 18 units of Hair Restoration Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,350 Wound Closure Tray II units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches because sterility may be compromised.
Customed, Inc. is recalling 3,000 units of gauze sponges due to inadequate validation of sterilization processes and package integrity.
Westbrook's Cannery is recalling 12-ounce jars of Hot Dilly Beans because the product may be underprocessed. Consumers in 11 states should stop using the product.
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway safety.
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 490 Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling EENT Pack I sterile medical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling 53 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised.
Customed, Inc. is recalling 105 Plastic Surgery Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,960 Foley Catheter Kits II 16FR distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Westbrook's Cannery is recalling 566 jars of Hot Dill Pickles because they may be underprocessed. The product was distributed to 11 states.
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction system.
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS due to inadequate validation of sterilization processes and package integrity.
Arrow International is recalling PICC and VPS Access Kits with Touhy Borst catheters due to saline leakage from unsecured connections. No injuries have been reported.
Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 152 units of Femoral Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 360 Ophthalmic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 508 packs of Premium Laparotomy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 228 PERI GYN PACK CS/6 units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Stryker is recalling Neptune 2 Waste Management System Docking Stations because a defective component may cause fluid leaks during use.
Halyard Health is recalling KimVent Multi-Access Port Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
Customed, Inc. is recalling 144 cases of impervious gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Intuitive Surgical is recalling 198 da Vinci Xi Surgical Systems because the Xi Stapler may have an exposed knife blade when used with P4 software.
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising airway protection.
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning.
Customed, Inc. is recalling polyreinforced surgical gowns due to inadequate validation of sterilization processes and package integrity.
The FDA is recalling Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. This Class II recall affects a specific lot distributed nationwide.
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 945 Minor Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 675 Minor Laparotomy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 18,000 units of 2"x2" 4-ply sterile gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Christie Cookie Co Inc is recalling Doubletree Cookie Dough because reports indicate the presence of clear and green plastic pieces in the cookies.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Customed, Inc. is recalling 1,866 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 244 units of Femoral Angiography Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 130 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Customed, Inc. is recalling obstetrical surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.
Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.
Panasonic is recalling specific cordless metal cutter saw kits because the lower blade guard can get stuck, exposing the blade and posing a laceration hazard.
Kenwood is recalling Blend-X PRO blenders because the lower blade can break during use, posing a laceration hazard. No injuries have been reported.
Cabrinha is recalling specific kiteboard control systems because the trim line can break, causing loss of control and posing a risk of injury.
Customed, Inc. is recalling 320 units of Femoral Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 327 units of Shoulder Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Customed, Inc. is recalling 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 4,800 irrigation trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Customed, Inc. is recalling 160 units of Foley Catheter Kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Customed, Inc. is recalling 690 Wound Management Tray II units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 300 units of medical leggings used for surgical and patient care procedures due to inadequate sterilization validation and package integrity issues.
Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.
Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 176 units of Cysto Tur Pack Basic due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling 24 units of Face Lift medical kits due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 370 units of Angiography Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 81 orthopedic implants distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 21 units of Retina Pack 7/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 39 sterile hip and knee replacement kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Bosch Security Systems is recalling approximately 950 Radion wireless smoke alarms because they may fail to alert consumers to a fire.
Baja Motorsports is recalling about 4,600 gas-powered mini bikes because the front fork can separate from the wheel, posing fall and crash hazards.
Covidien LLC is recalling specific Mahurkar Elite Acute Dual Lumen Catheter Trays because their sterility may be compromised.
Customed, Inc. is recalling 390 packs of Premium O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 2,142 units of Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling 172 vials of Artesunate Lyophilized Powder for Injection due to potential penicillin cross-contamination.
Customed, Inc. is recalling 130 packs of Urology Customed Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Fanfold Drapes due to inadequate validation of sterilization processes and package integrity, posing a potential risk of infection.
Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 123 Neuro Spine Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 180 packs of Arthroscopy PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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