The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

501–600 of 686

  • HighFDA (Devices)·Z-1603-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2019·2019-06-05

    Maquet Getinge ROTAFLOW Support Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling ROTAFLOW Support Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2019·2019-06-05

    Maquet Getinge Circulatory Circuits Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific circulatory circuits because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2019·2019-06-05

    Maquet Getinge Small Adult Cardiac Surgery Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific Small Adult Cardiac Surgery Tubing Sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2019·2019-06-05

    Maquet Getinge Neonate Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonate tubing sets because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2019·2019-06-05

    Maquet Getinge Pediatric Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric packs for extracorporeal circulation because a design issue may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1614-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2019·2019-06-05

    Maquet Getinge-BEQ-T 53400 Adaption Pack Recall for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Pediatric ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2019·2019-06-05

    Maquet Getinge Open Heart Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Open Heart Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2019·2019-06-05

    Maquet Getinge Priming Lines Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific priming lines for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1504-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 3700 Tubing Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2019·2019-06-05

    ThermaCare HeatWraps Recalled for Potential Skin Burn Risk

    PF Consumer Healthcare 1 LLC is recalling ThermaCare HeatWraps because some units may produce higher-than-specified temperatures, posing a risk of skin burns or blisters.

    Product
    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2019·2019-06-05

    Zimmer Biomet Alvarado Knee Holder Recalled for Foreign Material

    Zimmer Surgical Inc is recalling Alvarado and Alvarado II knee holder components due to potentially inadequate cleaning procedures that may leave foreign material on the devices.

    Product
    Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1644-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Getinge-BO-TOP tubing sets are being recalled because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.

    Product
    Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2019·2019-06-05

    Maquet Getinge Mayo Pulmonary Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Mayo Pulmonary Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2019·2019-06-05

    Maquet Getinge-T 5220 UAB Hospital Accessory Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because the design may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2019·2019-06-05

    Maquet Getinge Small Patient ECC Pack Recall for Sterility Assurance Issues

    Maquet Cardiovascular is recalling Small Patient ECC Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2019·2019-06-05

    Maquet Getinge-BO-TOP 26300 Custom Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Rotaflow Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2019·2019-06-05

    Maquet Getinge Adult Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Devices Due to Foil Separation

    Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2019·2019-06-05

    Maquet Pediatric Extracorporeal Circulation Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific pediatric tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2019·2019-06-05

    Maquet Getinge-BO-TOP Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2019·2019-06-05

    Maquet Getinge Custom Neonatal ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2019·2019-06-05

    Maquet Getinge-BEQ-T 3501 LVAD Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific LVAD tubing sets because a design feature may prevent sterilization gas from reaching all parts, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2019·2019-06-05

    Maquet Getinge-BEQ-T 8506 Transport Pack Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent sterilization gas from reaching the fluid path, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19132·2019-06-05

    Apple Recalls Three-Prong Wall Plug Adapters Due to Electric Shock Risk

    Apple is recalling three-prong wall plug adapters from its World Travel Adapter Kits because they can break and expose metal, posing an electric shock risk.

    Product
    Apple AC World Travel Adapter Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2019·2019-06-05

    Maquet Getinge-BO-TOP 20700 Small Patient Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 4901 Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 4901 Material: 701050839
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2019·2019-06-05

    Maquet Getinge-BO-T 6600 Tubing Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs used for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2019·2019-06-05

    NeuroLogica Recalls Samsung GM85 Mobile Digital X-ray Imaging Systems

    NeuroLogica is recalling 288 Samsung GM85 Mobile Digital X-ray Imaging Systems due to a potential safety latch issue that could cause the arm to fall.

    Product
    Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2019·2019-06-05

    Maquet Getinge Infant Custom Tubing Sets Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific infant custom tubing sets for extracorporeal circulation because the sterilization process may not have ensured sterility at the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1493-2019·2019-06-05

    Abbott TactiSys Quartz Equipment Recalled for Log Storage Defect

    Abbott is recalling 317 TactiSys Quartz Equipment units because a software defect prevents new log data from being stored, which may cause intermittent contact force data display.

    Product
    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1576-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1501-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 32200 ECC Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5502 ECC Pack Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of ECC packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2019·2019-06-05

    Maquet Pediatric CPB Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Pediatric CPB Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

    Teleflex Medical is recalling 4,312 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2019·2019-06-05

    Maquet Getinge Quadrox iD Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Quadrox iD Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2019·2019-06-05

    Maquet Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling pediatric extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2019·2019-06-05

    Maquet Pediatric Cardiac Surgery Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric cardiac surgery tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T-22800 Material: 701049506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2019·2019-06-05

    Maquet Getinge AV Loop Tubing Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific AV Loop tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1559-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2019·2019-06-05

    Maquet Getinge ECC Pump Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2019·2019-06-05

    Maquet Getinge BEQ-TOP 5210 ECC Set Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific BEQ-TOP 5210 ECC Sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 41200 ECC 1/4 Pump Pac Tubing Sets Recalled

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1419-2019·2019-06-05

    Heritage Candy Recalls Dark Chocolate Nonpareils Due to Almond Contamination

    Heritage Candy Company is recalling 197 units of First Street Dark Chocolate Nonpareils because some bags contain dark chocolate almonds, posing a tree nut allergy risk.

    Product
    First Street Dark Chocolate Nonpareils; 12 oz. stand up re-sealable plastic bags. Ingredients: Sweet Chocolate (sugar, chocolate liquor, cocoa butter, butter oil, soy lecithin, vanilla extract) seeds (sugar, cornstarch). Contains: milk, soy. Manufactured in a facility t
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1418-2019·2019-06-05

    Fiddyment Farms Pistachios Recalled for Undeclared Soy Protein

    Fiddyment Farms is recalling various Fiddy Fire pistachio products because they contain undeclared hydrolyzed soy protein.

    Product
    Fiddyment Farms Fiddy Fire In-Shell Pistachios 2.5 oz., 8 oz., 1 lb., 2 lb., 3 lb., 5 lb., Fiddyment Farms Fiddy Fire Pistachio In Shell 25 lb.; Fiddyment Farms Fiddy Fire Gift Tin 6 oz.; Fiddyment Farms Gourmet Sampler 2.5 oz.; Fiddyment Farms Deluxe Pistachio Lovers Gift Box 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1432-2019·2019-06-05

    Suja Organic Kombucha Recalled Due to Glass Fragments

    Suja Life LLC is recalling 31,079 cases of Organic Kombucha Variety Packs because consumers reported finding pieces of glass in the bottles.

    Product
    Suja Organic Kombucha - Variety Pack: 6 x 15.2 oz. glass bottle; 2 each of Ginger Lemon, Mixes Berries and Peach Ginger UPC 818617020737; DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-1431-2019·2019-06-05

    Suja Organic Kombucha Recalled Due to Glass Fragments

    Suja Life LLC is recalling 66,964 bottles of Organic Kombucha - Mixed Berries because consumers reported finding pieces of glass in the product.

    Product
    Suja Organic Kombucha - Mixed Berries: 15.2 oz. glass bottle; UPC 818617020362 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1564-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Recall for Sterility Assurance

    Maquet Cardiovascular is recalling specific ECC pump packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling BEQ-TOP 32200 ECC Packs because a design flaw may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01
    Category
    Medical Device
    Distribution
    Distributed nationwide

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