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.

22276–22300 of 50429

HighFDA (Devices)·Z-2839-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 54,816 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1297-2020·2020-09-02
Wegmans Recalls Grilled Shrimp Trays Due to Listeria Contamination Risk
Wegmans is recalling specific grilled shrimp trays sold in six states because they may be contaminated with Listeria monocytogenes.
Product
Grilled Shrimp Tray; Individual; Colossal grilled shrimp with sauce; grilled garlic shrimp with cocktail sauce; packaged in a plastic tray; package size varies; keep refrigerated
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2846-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling 3,542 Intra-Aortic Balloon Catheter kits worldwide due to potential endotoxin contamination.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1299-2020·2020-09-02
Wegmans Recalls Crab Claw Trays Due to Listeria Contamination Risk
Wegmans Food Markets is recalling Crab Claw Trays because they are potentially contaminated with Listeria monocytogenes. The recall affects units sold in six states.
Product
Crab Claw Tray; Tray for 2 or 18; crab claw platter with cocktail sauce; packaged in a plastic tray; package size varies; keep refrigerated
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2908-2020·2020-09-02
Neurovision Recalls Cobra x5 2-Ch EMG ET Tubes Due to Insulation Defect
Neurovision Medical Products Inc is recalling 1,058 Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften, potentially stopping EMG signal transmission.
Product
Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2867-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-1363-2020·2020-09-02
Organic Valley Egg Bites Recalled for Missing Allergen Labeling
Almark Foods is recalling Organic Valley Egg Bites because the packaging is missing the back panel with ingredient and allergen information.
Product
ORGANIC VALLEY EGG BITES feta & chives NET WT 4 OZ (114g) UPC# 0 93966 81195 7 Distributed by Organic Valley, La Farge, WI 54639
Category
Food
Distribution
1 state
HighFDA (Food)·F-1305-2020·2020-09-02
Wegmans Ready to Cook Salmon Recalled for Listeria Contamination
Wegmans is recalling Ready to Cook Salmon with Lemon Pepper Rub due to potential Listeria monocytogenes contamination. Consumers should discard or return the product.
Product
Wegmans Ready to Cook Salmon with Lemon Pepper Rub; 6 oz; salmon with lemon pepper rub; packaged in an oven ready tray; package size varies; keep refrigerated
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2842-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling specific Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2834-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1294-2020·2020-09-02
Wegmans Recalls Chicken French Meals Due to Listeria Risk
Wegmans Food Markets is recalling Chicken French meals potentially contaminated with Listeria monocytogenes. Consumers should discard or return the product.
Product
Wegmans Chicken French; Individual or Family Meals; plastic clamshell; keep refrigerated; size varies
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2896-2020·2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent incomplete sterilization.
Product
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1313-2020·2020-09-02
Wegmans Recalls Crab Cakes Due to Listeria Contamination Risk
Wegmans is recalling 4oz ready-to-cook crab cakes potentially contaminated with Listeria monocytogenes. Consumers in six states should discard or return the product.
Product
Crab Cake; 4oz.; Wegman;s ready to cook signature crab cake; 4oz, 1 each; packaged in a plastic clamshell; package size varies; keep refrigerated
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2866-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2851-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2894-2020·2020-09-02
Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
Product
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2852-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
Category
Medical Device
Distribution
0 states
HighNHTSA·20V533000·2020-09-02
Volkswagen Recalls 2020 Passat Vehicles Due to Air Bag Defect
Volkswagen is recalling 2020 Passat vehicles because the passenger air bag may deploy with excessive force, increasing injury risk.
Product
VOLKSWAGEN — VOLKSWAGEN PASSAT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1300-2020·2020-09-02
Wegmans Recalls Assorted Claw Platters Due to Listeria Contamination Risk
Wegmans is recalling Assorted Claw Platters potentially contaminated with Listeria monocytogenes. Consumers should discard or return the product.
Product
Assorted Claw Platter; Individual; Assorted claw platter with cocktail sauce and mustard sauce; packaged on a plastic tray; package size varies; keep refrigerated
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2857-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2892-2020·2020-09-02
Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates
Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.
Product
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2862-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2893-2020·2020-09-02
Karl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 650 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid patient infection.
Product
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2836-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·20176·2020-09-02
Hanamint Recalls Swivel Rockers and Gliders Due to Fall Hazard
Hanamint is recalling about 12,000 swivel rockers and gliders because the chair's post can separate from the base, posing a fall hazard.
Product
Swivel rocker and glider chairs
Category
Consumer Product
Distribution
Distributed nationwide