Baby and kids' product recalls
6675 federal recalls on file. Every federal recall touching baby and kids' products — toys, formula, baby food, cribs, strollers, child seats. Sourced from CPSC, FDA, USDA, and NHTSA, translated into plain English.
- 2014-09-10FDA-DeviceCustomed, IncClass ILABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTET
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 condition.
- 2014-09-10FDA-DeviceCustomed, IncClass ICESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X
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 condition.
- 2014-09-10FDA-DeviceCustomed, IncClass ICESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST. (1) SYRINGE 20cc W/0 NEEDLE LIL (1) SYRINGE EAR/ULCER 2oz. (1) BLANKET RECEIVING 100% COTION (1) CLAMP UMBILICAL CORD ST. (1) COVER TABLE REINFORCED 50" X 90" (1) SYRINGE 10CC W/0 NEEDLE L/LOCK (1) BOWL PLASTIC
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 condition.
- 2014-09-10FDA-DeviceCustomed, IncClass I0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF (1) UMBILICAL CORD CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) UTILITY BOWL 16oz LIF (2) TRAY ORGANIZER FULL DEEP (3) ABSORBENT TIP APPLICATOR (2) GLOVE EXAM MEDIUM (1) GOWN SURG
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 condition.
- 2014-09-10FDA-DeviceCustomed, IncClass ICustomed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15" LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 " X 58" SMS (1) GOWN SURG. REINFORCED X-LARGE
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 condition.
- 2014-09-10FDA-DeviceCustomed, IncClass ICustomed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
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 condition.
- 2014-09-10CPSCBenetton Trading U.S.A. Inc., of New York, N.Y.Benetton Recalls United Colors of Benetton Boys Jackets; Waist Drawstring Poses Entanglement Hazard
The jackets have a drawstring at the waist that could become snagged or caught in small spaces or vehicle doors, posing significant entanglement hazard to children.
- 2014-09-04CPSCLivie and Luca, of Emeryville, Calif.Livie & Luca Recalls Children's Shoes Due to Laceration Hazard
A metal thread inside the interior shoe liner can loosen and poke through the shoe lining, posing a laceration hazard to the user.
- 2014-09-04CPSCFGX International Inc., of Smithfield, R.I.FGX International Recalls Children's Sunglasses Due to Violation of Lead Paint Standard
Surface paint on the sunglasses contains excessive levels of lead, which is prohibited under federal law.
- 2014-09-02CPSCTray Vous LLC, of San Diego, Calif.Tray Vous Recalls Snack and Activity Trays for Strollers Due to Strangulation Hazard
The opening between the recalled tray and stroller seat bottom allows an unharnessed child's body to pass through but could trap a child's head, posing a strangulation hazard.
- 2014-08-27FDA-DeviceTomoTherapy IncorporatedClass IITomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotat
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
- 2014-08-27FDA-DeviceChildrens Medical VenturesClass IGel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
- 2014-08-27FDA-DrugTrigen Laboratories, Inc.Class IIITriveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
- 2014-08-27CPSCSwimwear Anywhere, Inc., of New York, N.Y.Swimwear Anywhere Recalls Little Marc Jacobs Girls Hooded Jackets Due to Strangulation Hazard (Recall Alert)
The jackets have a drawstring around the neck area which poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.
- 2014-08-22CPSCAce Bayou Corp., of New Orleans, La.Two Deaths Reported with Ace Bayou Bean Bag Chairs; Recall Announced Due to Suffocation and Choking Hazards
The zippers on the bean bag chairs can be opened by children who can then crawl inside, get trapped and suffocate or choke on the bean bag chair's foam beads.
- 2014-08-20FDA-DeviceBeevers Manufacturing & Supply, Inc.Class IILuma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.
- 2014-08-19CPSCBexco Enterprises Inc., of Montebello, Calif.Bexco Recalls Franklin & Ben Mason 4-in-1 Convertible Cribs Due to Fall and Entrapment Hazards
The crib front can separate from the side panels and create a hazardous gap that can allow a child to fall out or become entrapped between the front and side panels.
- 2014-08-19CPSCBRITA LP of Oakland, Calif.BRITA Recalls Children’s Water Bottles Due to Laceration Hazard
The lid can break into pieces with sharp points, posing a laceration hazard
- 2014-08-12CPSCDucks N Drakes, of Kampur, Uttar Pradesh, IndiaJPC Equestrian Recalls Stirrup Leathers Due to Fall Hazard
The stirrup leather can crack and break, posing a fall hazard to the rider.
- 2014-08-07CPSCL.L. Bean Inc., of Freeport, MaineL.L. Bean Recalls Children’s Sweaters Due to Choking Hazard (Recall Alert)
The spare button attached to the label on the inside seam of the sweaters can detach, posing a choking hazard.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IIVital Balance Formula, Bottles
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IICirculation and Energy Formula, Bottles
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IIKidney&Chi Plus, Bottles
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IIBTI Lean Formula, 400cc HDPE Bottle
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IIShark Formula, 250 cc HDPE Bottles
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodGM Manufacturing Inc.Class IICalcium Formula, 250 cc HDPE Bottles
GM Manufacturing is recalling dietary supplements due to significant violations of the cGMP regulations for dietary supplements.
- 2014-08-06FDA-FoodPUREFRUIT CHILE S.AClass IIHyVee applesauce; 3.5 oz applesauce in aluminum pouch with plastic screw-on lid; product is labeled in part, "***HyVee Mother's Choice Apple organic baby food NET WT 3.5 OZ (99g)***INGREDIENTS:ORGANIC APPLE, ASCORBIC ACID DISTRIBUTED BY HY-VEE, INC WEST DES MOINES, IA 50266 PRODUCT OF CHILE***" UPC Code: 075450082029
Purefruit Chile S.A. is recalling pouched applesauce due to the possibility of mold.
- 2014-08-06FDA-DrugDermamedics, L.L.C.Class IIDermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- 2014-08-06USDAClass IDo not eat Cavanaugh Smoked Sausage
Misbranding, Unreported Allergens
- 2014-07-31CPSCTianjin Tandem Industries Co. Ltd., of ChinaDynacraft Recalls Avigo Youth Bicycles Due to Fall Hazard; Sold Exclusively at Toys "R" Us
The front wheel on the bicycle can detach, posing a fall hazard.
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