The Recall Desk

Archive

May 2019 recalls

587 recalls were announced in May 2019.

What the numbers show

Critical
22
Severe
152
High
209
Moderate
184
Low
20

Of the 587 recalls this month scored against our rubric, 4% are Critical, 26% are Severe.

1–100 of 587

  • SevereUSDA FSIS·062-2019·2019-05-31

    Los Hernandez Tamales Recalls Chicken and Pork Products Produced Without Inspection

    Los Hernandez Tamales LLC is recalling approximately 9,090 pounds of chicken and pork tamales produced without federal inspection. No adverse reactions have been reported.

    Product
    Los Hernandez Tamales LLC — Los Hernandez Tamales, LLC Recalls Chicken and Pork Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·063-2019·2019-05-31

    Johnsonville Recalls Jalapeno Cheddar Sausage Due to Plastic Contamination

    Johnsonville is recalling ready-to-eat jalapeno cheddar smoked sausage links due to possible hard green plastic contamination. No adverse reactions have been reported.

    Product
    Johnsonville, LLC — Johnsonville, LLC. Recalls Ready-To-Eat Jalapeno Cheddar Smoked Sausage Links Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·064-2019·2019-05-31

    Perdue Recalls Chicken Products Due to Possible Bone Contamination

    Perdue Foods is recalling approximately 31,703 pounds of ready-to-eat chicken products that may contain pieces of bone material.

    Product
    PERDUE FOODS, LLC. — Perdue Foods LLC Recalls Perdue Simply Smart Organics Poultry Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V406000·2019-05-30

    Jayco Recalls 2020 Greyhawk Motorhomes Due to Brake Valve Defect

    Jayco is recalling 2020 Greyhawk motorhomes because a defective brake relay valve may cause extended stopping distances, increasing crash risk.

    Product
    JAYCO — JAYCO GREYHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V403000·2019-05-30

    Mazda Recalls 2018 CX-9 Vehicles Due to Wiring Harness Defect

    Mazda is recalling 2018 CX-9 vehicles because a wiring harness defect may disable the passenger air bag, turn signals, or engine starting system.

    Product
    MAZDA — MAZDA CX-9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19748·2019-05-30

    Excel Industries Recalls Zero-Turn Mowers Due to Fire Hazard

    Excel Industries is recalling about 5,400 zero-turn mowers because a wire tie could damage the fuel line, posing a fire hazard. No injuries have been reported.

    Product
    Zero turn lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19E037000·2019-05-30

    Seats Incorporated Recalls ABTS 6-Way Seats Due to Weld Defect

    Seats Incorporated is recalling ABTS 6-way seats because poor weld penetration may cause the seat to move unexpectedly, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1422-2019·2019-05-29

    Mecox Bay Dairy Sunrise Raw Milk Cheese Recalled for Listeria

    Mecox Bay Dairy is recalling Sunrise Raw Milk Cheese after New York State sampling detected Listeria monocytogenes. The product was distributed in New York and Chicago.

    Product
    Mecox Bay Dairy Sunrise Raw Milk Cheese in plastic wrap code L 2148 Size Range between .25 lb to 3 lb portions of a 3 lb wheel.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1396-2019·2019-05-29

    Life Rising Recalls HoliCare Metabolism Cleansing Tablets Due to High Lead Levels

    Life Rising Corporation is recalling 52 bottles of HoliCare Metabolism Cleansing tablets because they contain high levels of lead. The products were sold locally in the Chicago area and via mail order.

    Product
    HoliCare Metabolism Cleansing (MET-CLS) tablets, 60 count bottle
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1394-2019·2019-05-29

    Life Rising Holder-W Holder Warmer capsules recalled for high lead levels

    Life Rising Corporation is recalling Holder-W Holder Warmer capsules due to high lead levels. The products were sold locally in the Chicago area and via mail order.

    Product
    Life Rising Holder-W Holder Warmer capsules, 54 count bottle
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1403-2019·2019-05-29

    Great American Marketing Recalls Turkey Pepper Jack Sub Sandwiches

    Great American Marketing Company is recalling Turkey Pepper Jack 6" Sub Sandwiches in Texas due to potential Listeria monocytogenes contamination.

    Product
    Turkey Pepper Jack 6" Sub Sandwich with Jalapeno Ranch Dressing 5.5 OZ.
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·061-2019·2019-05-29

    J Deluca Fish Company Recalls Uninspected Frozen Yellow Walking Fish

    J Deluca Fish Company is recalling approximately 69,590 pounds of frozen Yellow Walking Fish imported from Vietnam without required import inspection.

    Product
    J Deluca Fish Company Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1287-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutica
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1286-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply is recalling Losartan Potassium Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1364-2019·2019-05-29

    Ortho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems because sample fluid may be dispensed to incorrect positions, potentially causing erroneous assay results.

    Product
    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1395-2019·2019-05-29

    Life Rising Neck Clear capsules recalled due to high lead levels

    Life Rising Corporation is recalling NECK-ND Neck Clear capsules because they contain high levels of lead. Consumers should stop using the product.

    Product
    Life Rising NECK-ND Neck Clear capsules, 54 count bottle
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1442-2019·2019-05-29

    Deshi Golden Raisins Recalled for Undeclared Sulfites

    DESHI DISTRIBUTORS, LLC is recalling Deshi Golden Raisins due to elevated levels of undeclared sulfites found by NYS.

    Product
    Deshi Golden Raisin, packaged in 3.5 oz, 7 oz. and 14 oz. clear plastic
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1401-2019·2019-05-29

    Jalapeno Pimento Cheese Sandwich Recalled for Listeria Risk

    Great American Marketing Company is recalling Jalapeno Pimento Cheese Sandwiches in Texas due to potential Listeria monocytogenes contamination.

    Product
    Jalapeno Pimento Cheese Sandwich 4.5 OZ.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1291-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutical
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1282-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs confirmed an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1289-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1284-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1288-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1283-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1285-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1290-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceut
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2019·2019-05-29

    Zimmer GmbH Recalls Drill System Due to Potential Material Deviation

    Zimmer GmbH is recalling Drill Sys 2.7 units because they may have been manufactured from a material different from specifications.

    Product
    Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1411-2019·2019-05-29

    Oakworks Lithotripsy Table Recalled for Incorrect Actuator Assembly Error

    Oakworks Inc. is recalling three Lithotripsy/Urology Tables due to an assembly error involving incorrect actuators for lateral and longitudinal movements.

    Product
    OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2019·2019-05-29

    Zimmer GmbH Recalls CBS Micro Countersink Cannulated Round-Shaft Screws

    Zimmer GmbH is recalling CBS micro countersink cannulated round-shaft screws because they may be made from the wrong material.

    Product
    CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1393-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Power Degradation

    Boston Scientific is recalling three Auriga XL 4007 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1450-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 4x90mm, round shaft, Item Number 502015640
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1457-2019·2019-05-29

    Zimmer CBS 4.5 Countersink Recalled for Potential Material Deviation

    Zimmer GmbH is recalling CBS 4.5 countersinks because they may have been manufactured from a different material than specified.

    Product
    CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1423-2019·2019-05-29

    Zimmer GmbH Recalls 2.5x135mm AO Drills Due to Material Concerns

    Zimmer GmbH is recalling 2.5x135mm AO Drills because they may be made from a different material than specified. The products were distributed to 41 US states.

    Product
    Drill, 2.5x135mm, AO, Item Number 502015142
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1464-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK Micro-Countersink Due to Material Concerns

    Zimmer GmbH is recalling V-TEK micro-countersinks because an investigation found they may be made from a different material than specified.

    Product
    V-TEK", micro-countersink, round shaft, Item Number 28.66.112
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1434-2019·2019-05-29

    Zimmer GmbH Recalls Stryker 3.5mm Screw Drills Due to Material Concerns

    Zimmer GmbH is recalling Stryker 3.5mm screw drills because they may have been manufactured from a different material than specified.

    Product
    Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1470-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm AO Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may be made from a different material than specified. The products were distributed to 41 US states.

    Product
    Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1430-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling 2.7mm orthopedic drills because they may be made from a different material than specified. The products were distributed to 40 US states.

    Product
    Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1486-2019·2019-05-29

    Zimmer GmbH Recalls Contra-Angle Drills Due to Material Concerns

    Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified.

    Product
    Drill, contra-angle, 1.5x85mm, Item Number ST502015706
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1412-2019·2019-05-29

    Elekta Recalls Leksell GammaPlan 11.1 Software Due to Margin Overestimation

    Elekta Instrument AB is recalling Leksell GammaPlan 11.1 software because the margin tool overestimates treatment margins in certain areas.

    Product
    Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1459-2019·2019-05-29

    Zimmer GmbH Recalls CBS 4.0 Countersink Due to Material Concerns

    Zimmer GmbH is recalling CBS 4.0 countersinks because they may have been manufactured from a different material than specified.

    Product
    CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1416-2019·2019-05-29

    Zimmer GmbH Recalls 15mm Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling 15mm surgical drills that may have been manufactured from incorrect materials. The products were distributed to 41 US states.

    Product
    Drill, 15mm stop, 1x76mm, AO , Item Number 502015115
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1424-2019·2019-05-29

    Zimmer GmbH Recalls Stryker 26mm Drill Due to Material Concerns

    Zimmer GmbH is recalling Stryker 26mm drills because they may be made from the wrong material. The products were distributed to 39 US states.

    Product
    Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1427-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 2.7mm orthopedic drills because an investigation found they may be made from a different material than specified.

    Product
    Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1453-2019·2019-05-29

    Zimmer GmbH Recalls CBS 7.5 Tap Due to Material Concerns

    Zimmer GmbH is recalling CBS 7.5 taps because they may be made from the wrong material. The products were distributed to 41 US states.

    Product
    CBS 7.5 tap, cannulated, AO, Item Number 503002041
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1476-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a different material than specified. The products were distributed to 41 US states.

    Product
    Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1466-2019·2019-05-29

    Zimmer V-TEK Cannulated AO Screws Recalled for Material Specification Deviation

    Zimmer GmbH is recalling V-TEK standard-countersink, cannulated, AO screws because they may have been manufactured from a material different from the defined specifications.

    Product
    V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1463-2019·2019-05-29

    Zimmer V-TEK Cannulated AO Screws Recalled for Material Deviation

    Zimmer GmbH is recalling V-TEK standard-countersink cannulated AO screws because they may have been manufactured from a different material than specified.

    Product
    V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-1392-2019·2019-05-29

    Trader Joe's Fire Roasted Vegetables Recalled for Undeclared Milk Allergen

    Ardo N.V. is recalling Trader Joe's Fire Roasted Vegetables with Balsamic Butter Sauce because the label lists butter but fails to declare milk.

    Product
    Trader Joe s Fire Roasted Vegetables With Balsamic Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0077 5175
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1373-2019·2019-05-29

    Polymer Technology Systems Recalls CHOL+HDL+GLU Test Strips

    Polymer Technology Systems is recalling CHOL+HDL+GLU test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    CHOL+HDL+GLU test strips, REF 2412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2019·2019-05-29

    Zimmer GmbH Recalls 26mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling 26mm orthopedic drills that may have been manufactured from a different material than specified.

    Product
    Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
    Category
    Medical Device
    Distribution
    42 states
  • HighNHTSA·19V401000·2019-05-29

    VCI Recalls Ambulances with Reversed Backup Camera Images

    VCI Emergency Vehicle Specialists is recalling ambulances where backup camera monitors may revert to factory settings, causing reversed images and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, FORD C4500, E-450, F-450, redundant F-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2019·2019-05-29

    Stryker Visum LED Surgical Lighting System Component Recall

    Stryker is recalling 3,176 EDS Light Suspension components for the Visum LED Surgical Lighting System due to a potential assembly defect in the joint.

    Product
    EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2019·2019-05-29

    Zimmer GmbH Recalls 19mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 19mm orthopedic drills because they may be made from the wrong material. The devices were distributed to 38 US states.

    Product
    Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1439-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than defined in specifications.

    Product
    Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1383-2019·2019-05-29

    Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors

    Beckman Coulter is recalling 2,059 UniCel DxH 600 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1310-2019·2019-05-29

    Integra LifeSciences Recalls MoniTorr CSF Drainage Systems Due to Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems because the LimiTorr Transducer Mount and MoniTorr Panel Mount stopcocks may break.

    Product
    MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Str
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2019·2019-05-29

    Beckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling UniCel DxH 800 analyzers because sporadic platelet results may be erroneously elevated without system flags, potentially leaving thrombocytopenia unrecognized.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient popula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2019·2019-05-29

    Zimmer GmbH Recalls 3.5mm Orthopedic Drill Due to Material Concerns

    Zimmer GmbH is recalling specific 3.5mm orthopedic drills because they may have been manufactured from a different material than specified.

    Product
    Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1458-2019·2019-05-29

    Zimmer CBS 4.0 Countersink Recalled for Material Specification Deviation

    Zimmer GmbH is recalling CBS 4.0 countersinks because they may have been manufactured from a material different from the defined specifications.

    Product
    CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1312-2019·2019-05-29

    Integra LifeSciences Recalls LimiTorr and MoniTorr Stopcock Components

    Integra LifeSciences is recalling LimiTorr and MoniTorr stopcock components due to a complaint trend regarding breakage.

    Product
    LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2019·2019-05-29

    Edwards Lifesciences Recalls EV1000 Clinical Platform Due to Fire Hazard

    Edwards Lifesciences is recalling EV1000 Clinical Platform monitors because liquid ingress into AC power outlets could cause an electrical short circuit and fire.

    Product
    EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2019·2019-05-29

    Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s g
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V398000·2019-05-29

    LGE Coachworks Recalls 2018-2019 Ford and Freightliner Vans for Camera Defect

    LGE Coachworks is recalling 2018-2019 Ford and Freightliner vans because back-up camera displays may revert to factory settings, reversing the image and increasing crash risk.

    Product
    FORD — FORD, FREIGHTLINER F-550, BUSINESS CLASS M2, F-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2019·2019-05-29

    Integra MoniTorr CSF Drainage System Recalled for Stopcock Breakage

    Integra LifeSciences is recalling MoniTorr CSF Drainage Systems due to a complaint trend regarding stopcock breakage.

    Product
    MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2019·2019-05-29

    Dornier Diode Laser Fibers Recalled for Sterility Compromise

    Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.

    Product
    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.

    Product
    AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incis
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·19V399000·2019-05-29

    HINO 268 and 338 Vehicles Recalled for Backup Camera Display Defect

    ITI is recalling 2018-2019 HINO 268 and 338 vehicles because backup camera displays may revert to factory settings, causing reversed images and increasing crash risk.

    Product
    HINO — HINO 268, 338
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling eight Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, exci
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1415-2019·2019-05-29

    Stryker 15mm Drill Recalled for Potential Material Deviation

    Zimmer GmbH is recalling Stryker 15mm drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
    Category
    Medical Device
    Distribution
    42 states
  • HighNHTSA·19V400000·2019-05-29

    PL Custom Recalls 2017-2019 Ambulances Due to Reversed Backup Camera Image

    PL Custom is recalling 2017-2019 Type I and III ambulances because backup camera monitors may revert to factory settings, reversing the image and increasing crash risk.

    Product
    PL CUSTOM — PL CUSTOM TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2019·2019-05-29

    Zimmer GmbH Recalls Osteofresh Arthrodesis Drills Due to Material Concerns

    Zimmer GmbH is recalling specific Osteofresh arthrodesis drills because they may have been manufactured from a material different from the specifications.

    Product
    Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1397-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling 18 Auriga 30 laser systems worldwide because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, exc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1448-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK IVP Step Drills Due to Material Concerns

    Zimmer GmbH is recalling V-TEK IVP step drills because an investigation found they may be made from a different material than specified.

    Product
    V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1454-2019·2019-05-29

    Zimmer GmbH Recalls MaxiCan 4.5 Countersink Due to Material Concerns

    Zimmer GmbH is recalling MaxiCan 4.5 countersinks because they may be made from a different material than specified. The products were distributed to 40 US states.

    Product
    MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1462-2019·2019-05-29

    Zimmer V-TEK Orthopedic Screws Recalled for Potential Material Deviation

    Zimmer GmbH is recalling V-TEK standard-countersink screws because they may have been manufactured from a different material than specified.

    Product
    V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-1391-2019·2019-05-29

    Trader Joe's Vegetable Melange Recalled for Undeclared Milk Allergen

    Ardo N.V. is recalling Trader Joe's Vegetable Melange in Seasoned Butter Sauce because the label lists butter but fails to declare milk.

    Product
    Trader Joe s Vegetable Melange In Seasoned Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0033 7038
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1393-2019·2019-05-29

    Haikui Abalone in Brown Sauce Recalled for Undeclared Oyster Sauce

    Haiku(Us) Mr Ocean Seafood Corp. is recalling Haikui Abalone in Brown Sauce due to undeclared oyster sauce, a potential allergen.

    Product
    Haikui Abalone in Brown Sauce 3 oz pouch bag,UPC Code: 719926149198
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1488-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Orthopedic Screws Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated orthopedic screws because they may have been manufactured from a material different from specifications.

    Product
    CBS high, countersink, cannulated, AO, Item Number ST503004542
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1480-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a different material than specified.

    Product
    Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1481-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630
    Category
    Medical Device
    Distribution
    42 states

Looking for a different month? Back to 2019.