The Recall Desk

Archive

September 2014 recalls

675 recalls were announced in September 2014.

What the numbers show

Critical
61
Severe
148
High
363
Moderate
91
Low
12

Of the 675 recalls this month scored against our rubric, 9% are Critical, 22% are Severe.

Which agencies issued them

501–600 of 675

  • HighFDA (Devices)·Z-2503-2014·2014-09-10

    Customed Recalls Minor Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling 200 units of EO sterilized minor packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2014·2014-09-10

    Customed Recalls Basic Pack FPSC Florham Pack Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Basic Pack FPSC Florham Pack surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2014·2014-09-10

    Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Lithotomy Pack III surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2014·2014-09-10

    Customed Recalls Laparoscopic Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling specific lots of laparoscopic colorectal surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2014·2014-09-10

    Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 19 lots of EO-sterilized laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Basic Pack IV surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2322-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,564 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    CESAREAN 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) C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2014·2014-09-10

    Customed Recalls Ophthalmic Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,382 units of ophthalmic packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2014·2014-09-10

    Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

    Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

    Product
    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2014·2014-09-10

    Customed Recalls Cesarean Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 968 units of EO sterilized cesarean surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41 " X 58" SMS LIF (5) TOWEL ABSORBENT 15" X 20" LIF (15) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (2) COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2014·2014-09-10

    Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits

    Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.

    Product
    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 843 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 154 units of Laparoscopy packs (Code 900-3178) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2447-2014·2014-09-10

    Customed Recalls Laparoscopy Chole System Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling specific lots of Laparoscopy Chole System Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2014·2014-09-10

    Customed Recalls Cataract Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling cataract surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2014·2014-09-10

    Customed Recalls Cysto TUR Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling Cysto TUR Pack Basic surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2014·2014-09-10

    Customed Recalls Breast Pack MRT Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 306 units of Breast Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2014·2014-09-10

    Customed Major Laparotomy Pack Recalled for Potential Sterility Loss

    Customed is recalling Major Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO steriliz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage

    Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Towels Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 26 lots of EO sterilized surgical towels because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2505-2014·2014-09-10

    Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues

    Customed is recalling 171 units of Shoulder Pack Code 900-2766 because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2014·2014-09-10

    Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch

    Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.

    Product
    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling orthopedic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2014·2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 681 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2014·2014-09-10

    Customed Recalls D & C Laparoscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling D & C Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2014·2014-09-10

    Customed Recalls Breast Augmentation Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling breast augmentation packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2014·2014-09-10

    Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling liposuction packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2592-2014·2014-09-10

    MedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling

    Medical Components, Inc. is recalling 110 Split Cath III Trays because they were incorrectly labeled as 32CM instead of 28CM.

    Product
    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2582-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings due to a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2566-2014·2014-09-10

    Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up

    Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.

    Product
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replace
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2585-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1572-2014·2014-09-10

    Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

    Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

    Product
    OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2014·2014-09-10

    Siemens Recalls V5Ms Transesophageal Ultrasound Transducers Due to Material Deterioration

    Siemens is recalling 321 V5Ms transesophageal ultrasound transducers because the material covering the articulating section has deteriorated.

    Product
    V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2591-2014·2014-09-10

    Mentor Saline Breast Implant Sizer Recalled for Volume Labeling Error

    Mentor Texas, LP. is recalling 34 units of saline breast implant sizers because the device labeling states 330cc while the actual device volume is 380cc.

    Product
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the bre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2573-2014·2014-09-10

    Pioneer Surgical Technology Recalls Streamline CT Set Screws

    Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.

    Product
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2568-2014·2014-09-10

    Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error

    Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.

    Product
    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·14V540000·2014-09-09

    GM Recalls 2008-2013 Vehicles for Ignition Key Knee Interference Risk

    General Motors is recalling 2008-2009 Pontiac G8 and 2011-2013 Chevrolet Caprice vehicles because the driver's knee may accidentally knock the ignition key out of the run position, potentially disabling safety systems.

    Product
    PONTIAC — PONTIAC, CHEVROLET G8, CAPRICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E060000·2014-09-09

    Clean Fuel USA Recalls LPI Fuel Rails for Propane Leak Risk

    Clean Fuel USA is recalling specific LPI fuel rails for 6 and 8-liter engines because improperly secured injectors or leaking tubes may cause a propane leak, leading to stalling or fire.

    Product
    FUEL SYSTEM, OTHER:DELIVERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V543000·2014-09-09

    GM Recalls 2014 Chevrolet Sonic Vehicles for Air Bag Defect

    General Motors is recalling 2014 Chevrolet Sonic vehicles because a steering column electrical issue may limit air bag deployment in severe crashes.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V541000·2014-09-09

    GM Recalls 2013-2015 Cadillac XTS and Chevrolet Impala for Brake Fire Risk

    General Motors is recalling 2013-2015 Cadillac XTS and 2014-2015 Chevrolet Impala vehicles because the electronic parking brake may not fully retract, potentially causing a fire.

    Product
    CHEVROLET — CHEVROLET, CADILLAC IMPALA, XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V542000·2014-09-09

    GM Recalls 2004-2007 Cadillac CTS-V and STS-V for Fuel Pump Fire Risk

    General Motors is recalling specific 2004-2007 Cadillac CTS-V and STS-V vehicles because fuel pump terminals may overheat, melt, and leak fuel, increasing the risk of stalling or fire.

    Product
    CADILLAC — CADILLAC CTS, STS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14271·2014-09-09

    Cabrinha Recalls Kiteboarding Control Systems Due to Spring Jamming Risk

    Cabrinha is recalling 1X and Overdrive 1X kiteboarding control systems because the Recoil spring can jam, causing loss of control and injury risk.

    Product
    Cabrinha Kiteboarding 1X and Overdrive 1X Control Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·056-2014·2014-09-06

    Perdue Recalls Raw Chicken Due to Temperature Processing Deviation

    Perdue Foods is recalling approximately 720 pounds of raw, fresh whole young chickens due to a temperature processing deviation. No adverse reactions have been reported.

    Product
    Perdue Foods, LLC — Maryland Firm Recalls Fresh, Raw Chicken Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·14V536000·2014-09-05

    Harley-Davidson Recalls 2015 XG500 and XG750 Motorcycles for Fuel Leak Risk

    Harley-Davidson is recalling 2015 XG500 and XG750 motorcycles because the fuel tank filler neck may not seal properly, creating a risk of fuel leaks and vehicle fire.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG750, XG500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V537000·2014-09-05

    Harley-Davidson Recalls 2014 Motorcycles Due to Clutch Master Cylinder Defect

    Harley-Davidson is recalling 105,746 model year 2014 motorcycles because a clutch master cylinder component may fail, causing the bike to creep forward.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXSBSE, FLHTCUTG, FLHX, FLHRSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V538000·2014-09-04

    Jet Company Recalls 2014 Side Dump Trailers Due to Suspension Bolt Failure

    Jet Company is recalling 84 model year 2014 Side Dump Trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    JET COMPANY — JET COMPANY SIDE DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14270·2014-09-04

    JVC 42-Inch Flat Panel Televisions Recalled for Tip-Over Risk

    AmTRAN Video is recalling JVC 42-inch flat panel televisions because the stand neck can crack, causing the TV to tip over and pose an impact injury risk.

    Product
    JVC 42-inch flat panel televisions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V529000·2014-09-04

    Chrysler Recalls 2013-2014 SRT Viper for Air Bag Deployment Defect

    Chrysler is recalling 2013-2014 SRT Vipers because inaccurate seat sensors may cause air bags to deploy at lower-than-designed velocities, increasing injury risk.

    Product
    SRT — SRT VIPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V534000·2014-09-04

    Monaco Holiday Rambler Fifth Wheel Trailers Recalled for Incorrect Tire Labels

    Allied Recreation Group is recalling 2015 Monaco Holiday Rambler fifth wheel trailers because incorrect Federal Certification labels may lead to improper tire inflation and increased crash risk.

    Product
    MONACO — MONACO HOLIDAY RAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14269·2014-09-04

    Livie and Luca Recalls Children's Shoes Due to Laceration Hazard

    Livie and Luca is recalling Carta and Cotton children's shoes because a metal thread inside the liner can poke through and cut a child's foot.

    Product
    Carta and "Cotton" Children's Shoes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2386-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Spicy Lava are being recalled due to potential Salmonella contamination in the carob powder used.

    Product
    Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1559-2014·2014-09-03

    Pediatric Cardioplegia Recalled for Aspergillus Microbial Contamination

    Central Admixture Pharmacy Services is recalling Pediatric Cardioplegia due to non-sterility and Aspergillus contamination. The product was distributed in Michigan and Wisconsin.

    Product
    PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1561-2014·2014-09-03

    Adenosine Injection Recalled for Microbial Contamination

    Central Admixture Pharmacy Services is recalling adenosine 90 mg injections in Michigan and Wisconsin due to Aspergillus species contamination.

    Product
    adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1568-2014·2014-09-03

    Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.

    Product
    Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Food)·F-2397-2014·2014-09-03

    McCormick Ground Oregano Recalled Due to Salmonella Contamination

    McCormick & Company is recalling specific bottles of ground oregano because a retail sample tested positive for Salmonella. Consumers should check their pantries for the affected product codes.

    Product
    McCormick Ground Oregano in 0.75 oz plastic bottle. UPC NUMBER: 52100003566 (as seen on label: 0-523561-6) MCCORMICK ITEM NUMBER: 900356
    Category
    Food
    Distribution
    39 states
  • CriticalFDA (Food)·F-2392-2014·2014-09-03

    Health Matters America Recalls Organic Traditions Sprouted Chia Seed Powder

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-1563-2014·2014-09-03

    Abrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection

    Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.

    Product
    MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2382-2014·2014-09-03

    Tiny Isle Mac Nut Fudge Recalled for Potential Salmonella Contamination

    Florimont, Inc. is recalling Tiny Isle Mac Nut Fudge because the carob powder used in the product is under recall for potential Salmonella contamination.

    Product
    Tiny Isle Mac Nut Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1565-2014·2014-09-03

    Pharmakon Recalls Midazolam HCl Vials Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 2 mg/ml vials because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-1562-2014·2014-09-03

    Central Admixture Pharmacy Recalls Contaminated Low Potassium Cardioplegia

    Central Admixture Pharmacy Services is recalling Low Potassium Cardioplegia doses due to non-sterility and Aspergillus contamination.

    Product
    LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1560-2014·2014-09-03

    Central Admixture Recalls del Nido Cardioplegia Due to Microbial Contamination

    Central Admixture Pharmacy Services is recalling del Nido Cardioplegia with Lidocaine due to non-sterility and Aspergillus contamination.

    Product
    del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1567-2014·2014-09-03

    Pharmakon Recalls Glycopyrrolate Syringes for Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling 200 pre-filled syringes of Glycopyrrolate 0.2 mg/ml because they contain undeclared benzyl alcohol.

    Product
    Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
    Category
    Drug
    Distribution
    4 states
  • SevereCPSC·14750·2014-09-03

    Great Innovations Recalls Ultrasonic Humidifiers Due to Fire Hazard

    Great Innovations is recalling about 70,000 Ultrasonic Clean Mist Humidifiers sold by QVC because water can enter the base and cause a fire hazard.

    Product
    Ultrasonic Clean Mist Humidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2384-2014·2014-09-03

    Tiny Isle Lava Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Lava Fudge is being recalled because it contains carob powder that may be contaminated with Salmonella.

    Product
    Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereNHTSA·14V527000·2014-09-03

    Western Star 4900 Trucks Recalled for Missing Anti-lock Brake Systems

    Daimler Trucks North America is recalling 2014-2015 Western Star 4900 trucks manufactured without Anti-lock Brake Systems, which increases the risk of wheel lockup and crashes.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2385-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Kauai Coconut are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereNHTSA·14V523000·2014-09-03

    Collins and Mid Bus School Buses Recalled for Body Joint Adhesive Defect

    NHTSA is recalling 281 model year 2014 Collins and Mid Bus school buses because inadequate adhesive on interior side panel joints may fail to meet federal safety standards.

    Product
    COLLINS — COLLINS, MID BUS DE416WR, DH416, SL408, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1556-2014·2014-09-03

    Alkermes Recalls VIVITROL Vials Due to Dose Delivery Failure

    Alkermes is recalling 4,364 vials of VIVITROL (naltrexone) nationwide because customer complaints reported the product failed to deliver the dose.

    Product
    VIVITROL — VIVITROL (NALTREXONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1566-2014·2014-09-03

    Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-2403-2014·2014-09-03

    Regeneca Recalls RegeneSlim Appetite Control Due to DMAA Presence

    Regeneca, Inc. is recalling RegeneSlim Appetite Control dietary supplements because FDA analysis found the product contains DMAA.

    Product
    RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2400-2014·2014-09-03

    Beta Labs Recalls PHEnFX Dietary Supplement Containing Unapproved DMAA

    Beta Labs is recalling 743 units of PHEnFX dietary supplements because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2399-2014·2014-09-03

    Beta Labs Recalls Phentylene Dietary Supplement Containing DMAA

    Beta Labs is recalling Phentylene capsules because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1564-2014·2014-09-03

    Abrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products

    Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.

    Product
    All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2383-2014·2014-09-03

    Tiny Isle Mint Crunch Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Mint Crunch Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Mint Crunch Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder cacao nibs, mint, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2402-2014·2014-09-03

    Honey Heaven Wholesale Recalls Organic Raw Carob Powder for Salmonella Risk

    Honey Heaven Wholesale is recalling Organic Raw Carob Powder due to potential Salmonella contamination. The product was distributed to processors and retail outlets in Oregon, Washington, and California.

    Product
    Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part "OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401 Certifie
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2395-2014·2014-09-03

    Health Matters America Recalls Organic Traditions Chia Seeds for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions chia seed products due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-2394-2014·2014-09-03

    Health Matters America Recalls Sprouted Chia Seed Powder for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder and related products due to possible Salmonella contamination.

    Product
    ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-2401-2014·2014-09-03

    Beta Labs Recalls Red Vipers Supplement Containing Illegal DMAA

    Beta Labs is recalling Red Vipers dietary supplements because they contain DMAA, an ingredient not permitted in dietary supplements.

    Product
    RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559819
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2389-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2379-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder that may be contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles: Gluten-Free, Raw, Vegan, Flavor varieties: Kauai Coconut, Mac Nut, Sea Salt, Mint Crunch, Spicy Lava. 1-oz Tiny Isle 4504 Kukui St, 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2358-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 3,850 lbs of Cheese Pre-mix DRWC due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states

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