Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

34201–34225 of 50502

HighFDA (Devices)·Z-0183-2017·2016-10-26
Windstone Medical Extremity Kits Recalled for Potential Sterility Compromise
Windstone Medical is recalling 3,829 Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0252-2017·2016-10-26
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
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2017·2016-10-26
Windstone Medical Packaging Recalls Mohs Closer Packs Due to Sterility Risk
Windstone Medical Packaging is recalling 340 Mohs Closer Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2017·2016-10-26
Windstone Medical Recalls Dr. Fetters Hand Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0124-2017·2016-10-26
X Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps
X Spine Systems Inc is recalling 182 units of Calix P PEEK Lumbar System PLIF Rasps because the tools may detach and become lodged in the surgical site.
Product
Calix P PEEK Lumbar System, PLIF Rasp
Category
Medical Device
Distribution
19 states
HighFDA (Food)·F-0170-2017·2016-10-26
Gourmet Foods Recalls Artichoke Bottom Ratatouille Due to E. coli Risk
Gourmet Foods, Inc. is recalling Artichoke Bottom Ratatouille because it was manufactured with flour recalled by General Mills for potential E. coli contamination.
Product
Artichoke Bottom Ratatouille Pack Size: 240 ea. per case UPC: 18010-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0282-2017·2016-10-26
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
Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2017·2016-10-26
Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside may contain splits or holes that compromise sterility.
Product
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0162-2017·2016-10-26
Windstone Medical Recalls Cath Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0236-2017·2016-10-26
Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 64 surgical kits because Medtronic gloves inside may have splits or holes, compromising sterility.
Product
Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2017·2016-10-26
ConMed Recalls CORE Suction Irrigation Handpiece Y-Tubing Sets
ConMed is recalling CORE Suction Irrigation Handpiece Y-Tubing sets because a crease in the packaging seal may compromise sterility.
Product
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2017·2016-10-26
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
Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0193-2017·2016-10-26
Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,596 general surgery kits because the disposable gloves inside may contain splits or holes that compromise sterility.
Product
General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0151-2017·2016-10-26
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 AMS kits.
Product
Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0169-2017·2016-10-26
Gourmet Foods Recalls Artichoke Hearts Due to E. coli Contamination Risk
Gourmet Foods, Inc. is recalling frozen artichoke hearts because they were manufactured with flour recalled for potential E. coli contamination.
Product
Artichoke Heart Breaded with Goat and Cheddar Cheese : Pack Size: 240 ea. per case; UPC: 13014-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0250-2017·2016-10-26
Windstone Medical Recalls OB/GYN Kits Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 18 OB/GYN kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0251-2017·2016-10-26
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
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0171-2017·2016-10-26
Gourmet Foods Recalls Breaded Artichoke Hearts Due to E. coli Risk
Gourmet Foods, Inc. is recalling breaded artichoke hearts because they were made with flour recalled for potential E. coli contamination.
Product
Artichoke Heart with Boursin Mousse Breaded Pack Size: 200 ea. per case UPC: 11784-03 Keep Frozen: Gourmet Foods, Hayward, CA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0181-2017·2016-10-26
Windstone ENT Surgical Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 123 ENT surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2017·2016-10-26
Windstone Medical Packaging Recalls Eye Tray Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling Eye Tray kits (PSS1834 and PSS1939) because Medtronic gloves within the kits may contain splits or holes that compromise sterility.
Product
Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0161-2017·2016-10-26
Union Bagel Shop Recalls 10-Grain Bread for Undeclared Milk
Union Bagel Shop is recalling 10-Grain Bread sold in Grande, Oregon, because the product contains butter, an undeclared milk ingredient.
Product
Package contains a business card for "***BAGEL SHOP***" "***10-GRAIN BREAD***Filtered Water, Sea Salt, Olive Oil, Sugar, Flour, Whole Wheat Flour, 10-Grain: Milled Wheat, Rye, Oats, Oat Bran, Corn, Millet, Triticale, Brown Rice, Flax Seed, Barley, Soya Beans, Yeast, &…
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0211-2017·2016-10-26
Windstone Medical Knee Arthroscopy Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling knee arthroscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2017·2016-10-26
Ortho-Clinical VITROS Chemistry TRIG Slides Recalled Due to NAC Interference
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Product
VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0152-2017·2016-10-26
Union Bagel Shop Recalls Double Cheese Bagels for Undeclared Allergens
Union Bagel Shop is recalling Double Cheese bagels because the packaging fails to declare wheat and milk ingredients.
Product
Package contains a business card for "***BAGEL SHOP***" "***Double Cheese: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast, Cheddar Cheese & Swiss Cheese.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states
HighFDA (Food)·F-0151-2017·2016-10-26
Union Bagel Shop Recalls Plain Bagels Due to Undeclared Wheat
Union Bagel Shop is recalling plain bagels because the packaging fails to declare wheat, a major food allergen.
Product
Package contains a business card for "***BAGEL SHOP***" "***Plain: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sugar, Sea Salt, Yeast.***" 2 bagels per package - plastic bag with twist tie.
Category
Food
Distribution
0 states