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.

35176–35200 of 50504

HighFDA (Devices)·Z-2187-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.
Product
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2173-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.
Product
Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1680-2016·2016-07-20
Magic Seasoning Blends Recalls Outback Steakhouse Batter for Peanut Allergen
Magic Seasoning Blends is recalling specific lots of Outback Steakhouse OSI Mama's Batter due to potential peanut protein contamination.
Product
OUTBACK STEAKHOUSE OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL 33609
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1679-2016·2016-07-20
Magic Seasoning Blends Recalls Onion Breader for Potential Peanut Presence
Magic Seasoning Blends is recalling 9,900 lbs of Onion Breader due to potential peanut protein in the milled flour used in the blend.
Product
ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL 33609
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1590-2016·2016-07-20
Silva International Recalls Dehydrated Chipotle Powder for Undeclared Gluten
Silva International is recalling 2,908 lbs of dehydrated chipotle powder because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.
Product
Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2163-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2211-2016·2016-07-20
Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging
Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.
Product
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number…
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2186-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2174-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing defects may have damaged internal sutures, leading to increased coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1684-2016·2016-07-20
Seasoned Flour Recalled for Potential Peanut Protein Presence
Magic Seasoning Blends, LLC is recalling Taste Bud's Seasoned Flour due to potential peanut protein contamination in certain lots.
Product
TASTE BUDS SEASONED FLOUR, ITEM# ZEAON1040, NET WT. 40 LBS.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.
Product
Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1228-2016·2016-07-20
Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials because the company cannot ensure the product is sterile.
Product
NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have compromised the sutures, leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2181-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2178-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1682-2016·2016-07-20
Outback Steakhouse Breading Mix Recalled for Potential Peanut Presence
Magic Seasoning Blends is recalling Outback Steakhouse Complete Breading Mix due to potential peanut protein in the flour used.
Product
OUTBACK STEAKHOUSE COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1214-2016·2016-07-20
Medaus Recalls Methyl B12 Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Methyl B12 1000mcg/mL vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.
Product
METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide