October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical: 136
Severe: 305
High: 392
Moderate: 171
Low: 31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 29% are Severe.

Which agencies issued them

201–300 of 1035

HighFDA (Devices)·Z-0142-2017·2016-10-26
Windstone Medical Recalls Arthroscopy Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 5,723 arthroscopy packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0150-2017·2016-10-26
Union Bagel Shop Recalls Onion and Garlic Bagels for Undeclared Wheat
Union Bagel Shop is recalling Onion/Garlic bagels due to undeclared wheat. The product was sold at one retail store in Grande, Oregon.
Product
Package contains a business card for "***BAGEL SHOP***" "***Onion/Garlic: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Onion & Garlic Flakes.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0261-2017·2016-10-26
Windstone Medical Packaging Recalls Plastic General Surgery Kits
Windstone Medical Packaging is recalling 15 Plastic General Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0174-2017·2016-10-26
Gourmet Foods Recalls Stretched Coconut Shrimp Due to E. coli Risk
Gourmet Foods, Inc. is recalling Stretched Coconut Shrimp because the flour used in manufacturing was recalled by General Mills due to potential E. coli contamination.
Product
Stretched Coconut Shrimp Pack Size: 180 ea. per case UPC: 22102-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0265-2017·2016-10-26
Windstone Medical Podiatry Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling specific podiatry kits because included Medtronic gloves may have splits or holes that compromise sterility.
Product
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0173-2017·2016-10-26
Gourmet Foods Recalls Breaded Cheese Ravioli Due to E. coli Risk
Gourmet Foods, Inc. is recalling Breaded Cheese Ravioli because it was manufactured with flour recalled by General Mills for potential E. coli contamination.
Product
Breaded Cheese Ravioli Pack Size: 1 oz. ea. 15 lb. per case UPC: 18890-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0216-2017·2016-10-26
Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 85 Lap Gallbladder Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.
Product
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0150-2017·2016-10-26
FDA Recalls Windstone Medical Basin Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 1,243 Basin Packs (kit AMS2497) because included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2017·2016-10-26
Medtronic Disposable Gloves in Laminectomy Kits Recalled for Sterility Risk
Windstone Medical Packaging is recalling 838 laminectomy kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.
Product
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0144-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0141-2017·2016-10-26
Kabobs Vegetable Springrolls Recalled Due to E. coli O121 Contamination
Kabobs Inc is recalling Vegetable Springrolls because they were made with flour contaminated with E. coli O121. The product was distributed to multiple states.
Product
VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0222-2017·2016-10-26
Windstone Medical Recalls Laparotomy Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 1,528 laparotomy packs because disposable gloves inside may have splits or holes that compromise sterility.
Product
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0143-2017·2016-10-26
Windstone Medical Packaging Recalls Augmentation Mammoplasty Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 132 Augmentation Mammoplasty Kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0120-2017·2016-10-26
Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters do not operate within the correct pressure pulse specifications.
Product
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Category
Medical Device
Distribution
14 states
HighNHTSA·16V776000·2016-10-26
Spartan K2 and K3 Vehicles Recalled for Throttle Wire Interference
Spartan Motors is recalling 2017 K2 and K3 vehicles because throttle wires may not be twisted, causing unintended acceleration or deceleration.
Product
SPARTAN — SPARTAN K3, K2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0195-2017·2016-10-26
Windstone Medical Packaging Recalls General Pack II Surgical Kits
Windstone Medical Packaging is recalling General Pack II surgical kits because the Medtronic gloves included may contain splits or holes that compromise sterility.
Product
General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0127-2017·2016-10-26
Kabobs Recalls Lobster Pot Pie Due to E. coli O121 Contamination
Kabobs Inc is recalling Lobster Pot Pie because it was manufactured with flour contaminated with E. coli O121.
Product
LOBSTER POT PIE, 180 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0281-2017·2016-10-26
Windstone Medical Packaging Recalls Upper Torso Surgical Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 546 Upper Torso Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2017·2016-10-26
Windstone Medical Vein Kit Recall Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 Vein Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.
Product
Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling disposable gloves included in Windstone Medical custom surgical kits because splits or holes may compromise sterility.
Product
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0155-2017·2016-10-26
Union Bagel Shop Recalls Bacon Cheddar Bagels for Undeclared Allergens
Union Bagel Shop is recalling Bacon Cheddar bagels due to undeclared wheat and milk ingredients. The products were distributed to one retail store in Grande, Oregon.
Product
Package contains a business card for "***BAGEL SHOP***" "***Bacon Cheddar: Flour, Filtered Water, Organic Shortening, Bacon Bits, Cheddar Cheese, Green Onions, Malt, Sugar, Sea Salt, Yeast..***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0221-2017·2016-10-26
Windstone Medical Packaging Recalls Laparotomy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 230 Laparotomy Kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0268-2017·2016-10-26
Windstone Medical Packaging Recalls Surgical Set-Up Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 2,225 surgical set-up packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Product
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2017·2016-10-26
Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Product
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0126-2017·2016-10-26
Kabobs Roasted Vegetable Tart Recalled Due to E. coli O121 Contamination
Kabobs Inc is recalling Roasted Vegetable Tarts because they were made with flour contaminated with E. coli O121.
Product
ROASTED VEGETABLE, 200 CT, TART Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Food)·F-0176-2017·2016-10-26
Gourmet Foods Recalls Shrimp Products Due to E. coli Contamination
Gourmet Foods is recalling frozen shrimp products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.
Product
Shrimp 21/25 Coconut Butterfly Pack Size: 200 ea. per case UPC: 23502-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0137-2017·2016-10-26
Merge Healthcare CADstream software recall for missing PURE filter message
Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.
Product
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0227-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0209-2017·2016-10-26
Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.
Product
HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0205-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone custom surgical kits because the gloves may contain splits or holes that compromise sterility.
Product
Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0220-2017·2016-10-26
Windstone Medical Recalls Laparoscopy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 184 laparoscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0271-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0172-2017·2016-10-26
Gourmet Foods Recalls Strudel Wild Mushroom Due to E. coli Risk
Gourmet Foods, Inc. is recalling Strudel Wild Mushroom products because they were manufactured with flour recalled by General Mills for potential E. coli contamination.
Product
Strudel Wild Mushroom Pack Size: 240 ea. per case UPC: 17338-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0218-2017·2016-10-26
Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2017·2016-10-26
Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0217-2017·2016-10-26
Windstone Medical recalls surgical kits with defective disposable gloves
Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.
Product
Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0145-2017·2016-10-26
Kabobs Mozzarella Calzone Recalled Due to E. coli O121 Contamination
Kabobs Inc is recalling Mozzarella Calzones prepared with flour contaminated with E. coli O121. The product was distributed to multiple states.
Product
MOZZARELLA CALZONE, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0245-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0206-2017·2016-10-26
Windstone Medical Head and Neck Surgical Kits Recalled for Sterility Risk
Windstone Medical Packaging is recalling Head and Neck surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0121-2017·2016-10-26
Kabobs Recalls Mac & Cheese Poppers Due to E. coli Contamination
Kabobs Inc is recalling Mac & Cheese Poppers because they were made with flour contaminated with E. coli O121.
Product
MAC & CHEESE POPPERS, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0184-2017·2016-10-26
Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits
Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0149-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2017·2016-10-26
Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 20 liposuction kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0154-2017·2016-10-26
Union Bagel Shop Recalls Italian Bagels for Undeclared Wheat
Union Bagel Shop is recalling Italian bagels sold in Grande, Oregon, due to undeclared wheat. The voluntary recall was initiated by the firm.
Product
Package contains a business card for "***BAGEL SHOP***" "***Italian: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Marinara Sauce, Oregano.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0156-2017·2016-10-26
Union Bagel Shop Recalls Sesame Seed Bagels Due to Undeclared Wheat
Union Bagel Shop is recalling sesame seed bagels because the packaging fails to declare wheat as an ingredient. The product was sold at one retail store in Grande, Oregon.
Product
Package contains a business card for "***BAGEL SHOP***" "***Sesame Seed: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Organic Sesame Seeds.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0175-2017·2016-10-26
Gourmet Foods Recalls Shrimp Coconut Brochettes Due to E. coli Flour
Gourmet Foods, Inc. is recalling Shrimp Coconut Brochettes because they were manufactured with flour recalled by General Mills for potential E. coli contamination.
Product
Shrimp Coconut Brochette Pack Size: 156 ea. per case UPC: 23811-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0295-2017·2016-10-26
Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure
Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.
Product
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Category
Medical Device
Distribution
37 states
HighFDA (Drugs)·D-0112-2017·2016-10-26
Supernus Recalls Trokendi XR Capsules Due to Assay Failure
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed to meet assay specifications.
Product
TROKENDI XR — TROKENDI XR (TOPIRAMATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2017·2016-10-26
ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise
ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.
Product
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2017·2016-10-26
Windstone Medical Recalls Morris Hysto Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 186 Morris Hysto Pack kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.
Product
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2017·2016-10-26
Windstone Medical Knee Packs Recalled for Potential Sterility Compromise
Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0136-2017·2016-10-26
Kabobs Mini Deep Dish Mushroom Pizza Recalled for E. coli O121
Kabobs Inc is recalling Mini Deep Dish Mushroom Pizza because it was made with flour contaminated with E. coli O121.
Product
MINI DEEP DISH MUSHROOM PIZZA, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0138-2017·2016-10-26
Olympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions
Olympus is recalling OER-Pro endoscope reprocessors because instructions may incorrectly suggest skipping precleaning steps. Users must conduct manual cleaning.
Product
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0087-2017·2016-10-26
Zimmer Biomet Recalls Uniflex Humeral Nail Guide Pins Due to Packaging Error
Zimmer Biomet is recalling 22 units of Uniflex Humeral Nail guide pins because they may be packaged with the wrong combination of pins, potentially causing surgical delays or injury.
Product
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant…
Category
Medical Device
Distribution
6 states
HighCPSC·17021·2016-10-26
H-E-B Recalls Brazos Embossed Star Chairs Due to Fall Hazard
H-E-B is recalling Brazos Embossed Star Chairs because weld defects may cause armrests to detach, posing a fall hazard. No injuries have been reported.
Product
Brazos Embossed Star Chairs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2017·2016-10-26
X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices
X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.
Product
Calix P PEEK Lumbar System, PLIF Trial
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-0156-2017·2016-10-26
Windstone Medical Breast Pack Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0142-2017·2016-10-26
Kabobs Recalls Mini Vegetable Springrolls Due to E. coli O121 Contamination
Kabobs Inc is recalling Mini Vegetable Springrolls because they were manufactured with flour contaminated with E. coli O121.
Product
MINI VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0160-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Product
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2017·2016-10-26
Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up
Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.
Product
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0207-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0168-2017·2016-10-26
Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.
Product
Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0277-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0234-2017·2016-10-26
Windstone Medical Recalls Major Lithotomy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling Major Lithotomy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·17706·2016-10-26
Hearth & Home Technologies Recalls Quadra Fire Explorer III Wood Stoves
Hearth & Home Technologies is recalling about 650 Quadra Fire Explorer III wood stoves because the top lid handle can disengage, causing the lid to slam shut on fingers.
Product
Quadra Fire® Explorer III wood stoves
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2017·2016-10-26
Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 255 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters are not operating within the correct pressure pulse specifications.
Product
25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0230-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising sterility.
Product
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0237-2017·2016-10-26
Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 140 Mammoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2017·2016-10-26
Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk
Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0239-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2017·2016-10-26
Windstone Medical Recalls Laparoscopic Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0148-2017·2016-10-26
Union Bagel Shop Recalls Cinnamon Raisin Bagels Due to Undeclared Wheat
Union Bagel Shop is recalling Cinnamon Raisin Bagels because the packaging fails to declare wheat as an ingredient. The products were sold at one retail store in Grande, Oregon.
Product
Package contains a business card for "***BAGEL SHOP***" "***Cinnamon Raisin: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Cinnamon, Raisin***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0264-2017·2016-10-26
Windstone Medical Recalls Podiatry Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 545 podiatry kits because disposable gloves inside may have splits or holes that compromise sterility.
Product
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0259-2017·2016-10-26
Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 430 Peri GYN surgical kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2017·2016-10-26
Medtronic Disposable Surgical Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0131-2017·2016-10-26
Kabobs Recalls Shrimp Empanadas Due to E. coli O121 Contamination
Kabobs Inc is recalling Shrimp Empanadas because they were manufactured with flour contaminated with E. coli O121.
Product
SHRIMP EMPANADA Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0254-2017·2016-10-26
Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 160 Ortho Minor Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0269-2017·2016-10-26
Windstone Medical Recalls Shoulder Arthroscopy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2017·2016-10-26
Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0248-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling disposable gloves used in custom surgical kits because splits or holes may compromise sterility.
Product
Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2017·2016-10-26
Synergetics Recalls 25 Gauge VersaVit 2.0 Vitrectomy Cutters
Synergetics Inc is recalling 25 gauge VersaVit 2.0 Vitrectomy Cutters because they may not operate within the correct pressure pulse specifications.
Product
25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0208-2017·2016-10-26
Windstone Medical Recalls Hernia Packs With Defective Gloves
Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0286-2017·2016-10-26
Windstone Medical Recalls Laparoscopy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0149-2017·2016-10-26
Union Bagel Shop Recalls Bagels for Undeclared Wheat
Union Bagel Shop is recalling bagels sold in Grande, Oregon, due to undeclared wheat, a major food allergen.
Product
Package contains a business card for "***BAGEL SHOP***" "***Pretzel Salt: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Pretzel Salt.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0177-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Product
Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2017·2016-10-26
Windstone Medical Packaging Recalls General Surgery Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 985 general surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Product
General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2017·2016-10-26
Windstone C-Section Kits Recalled Due to Potential Glove Splits or Holes
Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2017·2016-10-26
Windstone Medical Recalls General Surgery Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 168 General Surgery Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0133-2017·2016-10-26
Kabobs Sweet Potato Puffs Recalled Due to E. coli O121 Contamination
Kabobs Inc is recalling Sweet Potato Puffs because they were made with flour contaminated with E. coli O121.
Product
SWEET POTATO PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
Category
Food
Distribution
27 states
HighFDA (Devices)·Z-0224-2017·2016-10-26
Windstone Medical Recalls Lipo Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 40 Lipo Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2017·2016-10-26
Windstone Medical Packaging Recalls Surgical Set Up Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves that compromise sterility.
Product
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0255-2017·2016-10-26
Windstone Medical Recalls Ortho Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 92 Ortho Pack kits because they may contain defective gloves with splits or holes that compromise sterility.
Product
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0160-2017·2016-10-26
Union Bagel Shop Recalls Cinnamon Swirl Bagels for Undeclared Allergens
Union Bagel Shop is recalling Cinnamon Swirl bagels due to undeclared wheat and milk ingredients. The products were distributed to one retail store in Grande, Oregon.
Product
Package contains a business card for "***BAGEL SHOP***" "***CINNAMON SWIRL***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Yeast, Butter & Cinnamon***" plastic bag with twist tie.
Category
Food
Distribution
0 states

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