The Recall Desk

Archive

August 2019 recalls

831 recalls were announced in August 2019.

What the numbers show

Critical
20
Severe
249
High
270
Moderate
249
Low
43

Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.

201–300 of 831

  • SevereFDA (Drugs)·D-1784-2019·2019-08-21

    Infusion Options Recalls Ifosfamide Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Ifosfamide and Mesna infusion bags in New York due to a lack of assurance of sterility.

    Product
    IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1813-2019·2019-08-21

    Infusion Options Recalls SOLIRIS IV Products Due to Sterility Concerns

    Infusion Options, Inc. is recalling SOLIRIS 1200 mg and 900 mg IV products in New York due to a lack of assurance of sterility.

    Product
    SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1781-2019·2019-08-21

    Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.

    Product
    Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 17
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1782-2019·2019-08-21

    Infusion Options Recalls Granisetron Infusion Due to Sterility Concerns

    Infusion Options, Inc. is recalling Granisetron 1000 mcg/50 mL NS infusion products in New York due to a lack of assurance of sterility.

    Product
    GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1787-2019·2019-08-21

    Infusion Options Recalls Irinotecan Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Irinotecan infusion products in New York due to a lack of assurance of sterility.

    Product
    IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML D5W
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1803-2019·2019-08-21

    Infusion Options Recalls Pemetrexed Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Pemetrexed infusion products in New York due to a lack of assurance of sterility.

    Product
    PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PEMETREXED 1000 mg QS 100 ml 0.9% NACL IVPB; PEMETREXED 490 MG /100 ml NS IVPB; PEMETREXED 800 mg/ 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1802-2019·2019-08-21

    Panitumumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Panitumumab 400 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1758-2019·2019-08-21

    Infusion Options Recalls Cetuximab IV Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions in New York due to a lack of assurance of sterility.

    Product
    CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1819-2019·2019-08-21

    Ferric Carboxymaltose Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Ferric Carboxymaltose 750mg/50ml NS IVPB due to a lack of assurance of sterility. The product was distributed in New York.

    Product
    FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1799-2019·2019-08-21

    Infusion Options Recalls Paclitaxel Albumin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Paclitaxel Albumin infusions in New York due to a lack of assurance of sterility.

    Product
    PACLITAXEL ALBUMIN 185 mg /100 ml NS IVPB; PACLITAXEL ALBUMIN 160 MG / 100 ml NS IVPB; PACLITAXEL ALBUMIN 145 MG / 100 ml NS IVPB PACLITAXEL ALBUMIN 165 mg / 100 ml NS IVPB; PACLITAXEL ALBUMIN 150 mg /100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1807-2019·2019-08-21

    Infusion Options Recalls Ramucirumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific Ramucirumab infusion products in New York due to a lack of assurance of sterility.

    Product
    RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1816-2019·2019-08-21

    Infusion Options Recalls Velcade Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Velcade subcutaneous syringes in New York due to a lack of assurance of sterility.

    Product
    VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRINGE; VELCADE 4 mg / 1.6 ml SQ SYRINGE; VELCADE 2.75 mg / 1.1 ml SQ SYRINGE; VELCADE 2.6 mg / 1.04 ml SQ SYRINGE VELCADE 1.7 mg / 0.6
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1763-2019·2019-08-21

    Infusion Options Recalls Dacarbazine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Dacarbazine infusions in New York due to a lack of assurance of sterility.

    Product
    DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1814-2019·2019-08-21

    Infusion Options Recalls Topotecan Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Topotecan 1.24 mg/100 mL infusions in New York due to a lack of assurance of sterility.

    Product
    TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2266-2019·2019-08-21

    Medline Silicone Drain Recalled for Risk of Breaking During Use

    Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1777-2019·2019-08-21

    Infusion Options Recalls Fluorouracil Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Fluorouracil infusion products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; Fluorouracil 3920 MG QS 92 ML 0.9% NACL; Fluorouracil 3760 mg QS 100 ml NS CASS; Fluorouracil 4000 MG QS 92 ml 0.9% NACL; Fluorouracil 3140 MG QS 240 ML NS PUMP; Fluorouracil 2400 MG QS 96 ML 0.9% NACL F
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V617000·2019-08-21

    Volvo Recalls 2015 VNL Trucks for Front Axle Fracture Risk

    Volvo Trucks North America is recalling 2015 VNL trucks because front axles may fracture due to missed heat treating, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1788-2019·2019-08-21

    Iron Sucrose Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Iron Sucrose 200 mg/100 mL IV products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1796-2019·2019-08-21

    Infusion Options Recalls ORENCIA Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling ORENCIA 750 mg IV infusions in New York due to a lack of assurance of sterility.

    Product
    ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1810-2019·2019-08-21

    Infusion Options Recalls Rituximab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific Rituximab infusion bags in New York due to a lack of assurance of sterility.

    Product
    RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 1000 MG / 1000 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1994-2019·2019-08-21

    Mountain Rose Herbs Recalls Fennel Seed for Salmonella Risk

    Mountain Rose Herbs is recalling Fennel Whole Seed due to potential Salmonella contamination. The product was sold in the US and Canada.

    Product
    Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds, sold under Mountain Rose Herbs brand. The label is read in parts: "***Fennel Seed Whole ***NET WT *** Origin: Egypt *** MOUNTAIN ROSE HERB
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1772-2019·2019-08-21

    Infusion Options Recalls Durvalumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Durvalumab infusions in New York due to a lack of assurance of sterility.

    Product
    Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2066-2019·2019-08-21

    Medline Primary Warmer Pack Recalled for Unsafe Aluminum Levels

    Medline Industries is recalling 4,680 Primary Warmer Packs because the included Vyaire enFlow cartridge may release unsafe aluminum levels into the infusate.

    Product
    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Dispo
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1820-2019·2019-08-21

    American Health Packaging Recalls Aspirin and Dipyridamole Capsules

    American Health Packaging is recalling specific lots of Aspirin and Extended-release Dipyridamole Capsules due to an unknown impurity found in stability samples.

    Product
    Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2264-2019·2019-08-21

    Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2067-2019·2019-08-21

    Medline Centurion Convenience Kits Recalled for Infusion Set Defect

    Medline is recalling Centurion Convenience Kits containing BD Alaris Pump Infusion Sets due to a tubing defect that may cause over-infusion of medication.

    Product
    Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermitt
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1755-2019·2019-08-21

    Infusion Options Recalls Calcium Glucunate IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Calcium Glucunate 1 gm/100 mL IV bags in New York due to a lack of assurance of sterility.

    Product
    CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2263-2019·2019-08-21

    Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk

    Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, dr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1752-2019·2019-08-21

    Infusion Options Recalls Bevacizumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Bevacizumab infusion bags in New York due to a lack of assurance of sterility.

    Product
    BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG /
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1793-2019·2019-08-21

    Infusion Options Recalls Nivolumab IV Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling Nivolumab IV bags in New York due to a lack of assurance of sterility.

    Product
    NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1753-2019·2019-08-21

    Infusion Options Recalls Bleomycin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Bleomycin 18 Units / 100 mL NS IVPB products in New York due to a lack of assurance of sterility.

    Product
    BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1754-2019·2019-08-21

    Bortezomib Syringes Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Bortezomib subcutaneous syringes in New York due to a lack of assurance of sterility.

    Product
    BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE; BORTEZOMIB 2.31 MG / 0.92 ml SQ SYRINGE; BORTEZOMIB 2.7 mg / 1.08 ML SQ SYRINGE; BORTEZOMIB 1.45 mg / 0.58 ml SQ SYRINGE; BORTEZOMIB 2.25 mg (0.9 ML) SQ SYRINGE; BORTEZOMIB 1.98 mg / 0.79 ml SQ SYRINGE,
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1794-2019·2019-08-21

    Infusion Options Recalls Ondansetron Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling Ondansetron 8 mg/50 mL infusions in New York due to a lack of assurance of sterility.

    Product
    ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1808-2019·2019-08-21

    Infusion Options Recalls Remicade Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Remicade infusion bags in New York due to a lack of assurance of sterility.

    Product
    REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB; REM
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1800-2019·2019-08-21

    Infusion Options Recalls Paclitaxel Protein Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.

    Product
    PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1795-2019·2019-08-21

    Infusion Options Recalls OPDIVO Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling OPDIVO 200 mg and 480 mg infusion products in New York due to a lack of assurance of sterility.

    Product
    OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1791-2019·2019-08-21

    Infusion Options Recalls Methylprednisolone Due to Sterility Concerns

    Infusion Options, Inc. is recalling Methylprednisolone 10 mg/0.16 mL IVP products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1759-2019·2019-08-21

    Infusion Options Recalls Cisplatin Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Cisplatin infusion products due to a lack of assurance of sterility. The recall is limited to New York.

    Product
    Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml 0.9% NACL; Cisplatin 36 MG / 500 ML NS IVPB; Cisplatin 73 MG QS 500 ml 0.9% NACL WITH Mannitol 12.5 G; Cisplatin 70 MG / 500 ml NS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1818-2019·2019-08-21

    Infusion Options Recalls Vincristine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling specific vincristine infusion products in New York due to a lack of assurance of sterility.

    Product
    VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1773-2019·2019-08-21

    Entyvio Infusion Recalled for Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Entyvio 300 mg/250 mL due to a lack of assurance of sterility. The product was distributed in New York.

    Product
    ENTYVIO 300 MG /250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V616000·2019-08-21

    Mack Recalls 2015 Pinnacle Trucks Due to Front Axle Fracture Risk

    Mack Trucks is recalling 2015 Pinnacle (CXU) vehicles because front steer axles may have missed a heat-treating step, potentially causing them to fracture and leading to a loss of vehicle control.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1991-2019·2019-08-21

    Belfonte Frozen Vanilla Yogurt Recalled for Undeclared Peanuts

    Belfonte Ice Cream & Dairy Foods Co is recalling 1,246 units of frozen vanilla yogurt because peanut butter ice cream was placed in the wrong containers.

    Product
    FROZEN VAN YOG, in 3 gallon cardboard buckets
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2054-2019·2019-08-21

    Hill & Valley Chocolate Chunk Cookies Recalled for Undeclared Milk and Soy

    Hill & Valley Inc. is recalling Freshness Guaranteed Chocolate Chunk cookies due to undeclared milk and soy allergens.

    Product
    Freshness Guaranteed Chocolate Chunk cookie Clear plastic clam shell Net wt. 14 oz. UPC: 0007874209234
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2244-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.1x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2019·2019-08-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Issues

    Siemens Medical Solutions USA is recalling SOMATOM Definition AS CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.

    Product
    SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physicia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x32 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V612000·2019-08-21

    Rolls-Royce Cullinan Recall for Dim Brake Lights

    BMW is recalling 2019 Rolls-Royce Cullinan vehicles because brake lights may not be bright enough, increasing crash risk.

    Product
    ROLLS-ROYCE — ROLLS-ROYCE CULLINAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2019·2019-08-21

    Siemens SOMATOM Edge Plus CT Systems Recalled for Software Issues

    Siemens is recalling SOMATOM Edge Plus CT systems due to four safety-related software issues in syngo.CT version VB10A that may cause scan aborts.

    Product
    SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2019·2019-08-21

    Siemens SOMATOM Force CT Systems Recalled for Software Scan Abort Issues

    Siemens Medical Solutions is recalling SOMATOM Force CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x30 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2019·2019-08-21

    Pega Medical Recalls SLIM Handle Components Due to Jamming Risk

    Pega Medical Inc. is recalling 19 SLIM Handle components because an internal ring may detach, causing the handle to jam with the driver.

    Product
    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2243-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.6x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2019·2019-08-21

    Siemens SOMATOM Confidence CT Systems Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling SOMATOM Confidence CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x100 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2019·2019-08-21

    Canadian Hospital Specialties Recalls Polyurethane Feeding Tubes Due to Connector Detachment

    Canadian Hospital Specialties is recalling specific lots of MED-RX polyurethane feeding tubes because the connector may detach from the tube.

    Product
    MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2248-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x36 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2019-2019·2019-08-21

    Kerry Predust Batter Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 104 bags of Predust/Batter due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine states.

    Product
    Predust/Batter, Item Number 30753195.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-1764-2019·2019-08-21

    DARATUMUMAB infusion products recalled due to lack of assurance of sterility

    The FDA is recalling DARATUMUMAB infusion solutions because sterility cannot be assured, creating a potential infection risk.

    Product
    DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-2055-2019·2019-08-21

    Amy's Kitchen Recalls Broccoli and Cheddar Bake Due to Foreign Material

    Amy's Kitchen Inc. is recalling 5,207 cases of Broccoli & Cheddar Bake due to consumer complaints of black plastic found in the product.

    Product
    Amy's Bowls - Broccoli & Cheddar Bake; Net Wt. 9.5 oz. (269g) Perishable - Keep Frozen. Microwave or regular oven. UPC: 0 42272 00811 7 Amy's kitchen Inc., P.O. Box 7129, Petaluma, CA 94955 INGREDIENTS: RICE PASTA (ORGANIC RICE FLOUR, FILTERED WATER, ORGANIC POTATO STARCH,
    Category
    Food
    Distribution
    27 states
  • HighFDA (Drugs)·D-1761-2019·2019-08-21

    Infusion Options Recalls Cyclophosphamide Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Cyclophosphamide infusion products in New York due to a lack of assurance of sterility.

    Product
    Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2279-2019·2019-08-21

    BD Vacutainer Fluoride Tubes Recalled Due to Missing Preservative Additive

    Becton Dickinson is recalling 247,000 blood alcohol test tubes because they lack the required fluoride additive, which may cause inaccurate test results if samples are stored for more than two days.

    Product
    BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x105 (Item 19669) due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2053-2019·2019-08-21

    Kerry Breader Recalled Due to Nylon String Foreign Material

    Kerry, Inc. is recalling 258 bags of Breader because the product contains nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Breader, Item Number 30753230.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-1757-2019·2019-08-21

    Infusion Options Recalls Carfilzomib Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions in New York due to a lack of assurance of sterility.

    Product
    CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2245-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1769-2019·2019-08-21

    Infusion Options Recalls Docetaxel Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Docetaxel infusion bags in New York due to a lack of assurance of sterility.

    Product
    DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 150 MG / 250 ml NS IVPB; DOCETAXEL 137 mg / 250 ml 0.9% NACL IVPB; DOCETAXEL 130 MG/ 250 ml NS IVPB; DOCETAXEL 140 MG/ 250 ml NS IVPB
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2232-2019·2019-08-21

    Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components

    Zimmer Biomet is recalling 28 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed in the US and internationally.

    Product
    Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-1997-2019·2019-08-21

    Kerry Batter Mix Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 4,765 bags of Batter Mix due to the presence of nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Batter Mix, Item Number 30753149.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2256-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x110 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1815-2019·2019-08-21

    Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling multiple Trastuzumab infusion bags in New York due to a lack of assurance of sterility.

    Product
    TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG /
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1990-2019·2019-08-21

    Entenmann's Little Bites Cookies Recalled for Possible Plastic Pieces

    BIMBO Bakeries USA Inc. is recalling 160,000 boxes of Entenmann's Little Bites Soft Baked Cookies due to a manufacturing failure that may have introduced small plastic pieces into the product.

    Product
    Entenmann's Little Bites Soft Baked Cookies (5 pack Mini Chocolate Chip variety) Net Weight of 5ct box 6.88oz. 5 pouches per package, package type is carton, units per case 12
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-2259-2019·2019-08-21

    BioPro K-Wire HBS Sterile Lots Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1783-2019·2019-08-21

    Infusion Options Recalls HERCEPTIN Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling HERCEPTIN infusion bags in New York due to a lack of assurance of sterility.

    Product
    HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2253-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x115 due to a manufacturing flaw in the sterile barrier system. The devices are intended for orthopedic surgical procedures.

    Product
    Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2019·2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system that may compromise sterility.

    Product
    K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2019·2019-08-21

    NeuroLogica HS70A Ultrasound Systems Recalled for Probe Overheating Risk

    NeuroLogica is recalling HS70A Diagnostic Ultrasound Systems due to a potential risk of probes overheating when users decrease the Doppler Sample Volume size in Doppler Only mode.

    Product
    HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2019·2019-08-21

    BioPro K-Wire HBS Sterile Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1751-2019·2019-08-21

    Infusion Options Recalls Azacitidine Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling Azacitidine syringes in New York due to a lack of assurance of sterility.

    Product
    AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2276-2019·2019-08-21

    NeuroLogica WS80A Diagnostic Ultrasound System Recalled for Probe Overheating Risk

    NeuroLogica is recalling WS80A Diagnostic Ultrasound Systems because probes may overheat when users decrease the Doppler Sample Volume size in Doppler Only mode.

    Product
    WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2019·2019-08-21

    Luminex ARIES Flu A/B & RSV Assay Recalled for Seal Defects

    Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.

    Product
    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2233-2019·2019-08-21

    Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components

    Zimmer Biomet is recalling 23 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The products were distributed to 18 US states, Japan, and the Netherlands.

    Product
    Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2258-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x38 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2019·2019-08-21

    BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 2.5x170mm due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2019·2019-08-21

    Siemens SOMATOM CT Systems Recalled for Software Scan Abort Risk

    Siemens is recalling SOMATOM Definition Flash CT systems due to four software issues that may cause scans to abort.

    Product
    SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained phys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2019·2019-08-21

    Luminex ARIES GBS Assay Recalled for Partially Sealed Side Cassettes

    Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.

    Product
    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2251-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.

    Product
    Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x34 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2019·2019-08-21

    Elekta iGUIDE System Recalled for Potential Position Monitoring Error

    Elekta is recalling 374 iGUIDE Systems because they may incorrectly monitor 3D position. The recall covers devices distributed nationwide and worldwide.

    Product
    iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2019·2019-08-21

    Luminex Recalls ARIES C. difficile Assay Due to Seal Defects

    Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.

    Product
    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2241-2019·2019-08-21

    BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw

    BioPro, Inc. is recalling K-Wire Sterile Single Trochar units due to a manufacturing flaw in the sterile barrier system.

    Product
    K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2249-2019·2019-08-21

    BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x95 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2019·2019-08-21

    Siemens SOMATOM Drive CT Systems Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling SOMATOM Drive CT systems due to four software issues that may cause scan aborts.

    Product
    SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x90 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2019·2019-08-21

    BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

    BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.

    Product
    Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2019·2019-08-21

    Siemens CT Systems Recalled for Software Issues Causing Scan Aborts

    Siemens is recalling SOMATOM Definition Edge CT systems due to four safety-related software issues in syngo.CT version VB10A that may result in scan aborts.

    Product
    SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2012-2019·2019-08-21

    Kerry Breader Recalled for Nylon String Foreign Material

    Kerry, Inc. is recalling 309 bags of Breader (Item 30753187.49) because the product contains nylon string. The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    Breader, Item Number 30753187.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2002-2019·2019-08-21

    Kerry Recalls CKN Fried Breader Due to Nylon String Foreign Material

    Kerry, Inc. is recalling 810 bags of CKN Fried CKN Breader because the product contains foreign material (nylon string). The product was distributed to manufacturers and food service distributors in nine US states.

    Product
    CKN Fried CKN Breader, Item Number 30753155.49, Net Wt. 50 lb, Distributed by Kerry Ingredients & Flavours, Beloit, WI
    Category
    Food
    Distribution
    10 states

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