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.

16201–16225 of 53092

HighFDA (Drugs)·D-1420-2022·2022-08-31
PREVACID Lansoprazole 15mg Capsules Recalled Due to Storage Conditions
Family Dollar Stores is recalling PREVACID 24HR Lansoprazole 15mg capsules distributed nationwide from April 30 to June 10, 2022, because the product was stored at improper temperatures in violation of manufacturing standards. Consumers should not use this product and should contact Family Dollar Stores for a refund.
Product
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1564-2022·2022-08-31
NUCLISENS easyMAG Magnetic Silica Reagent Kit Contamination Recall
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
Product
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Category
Medical Device
Distribution
24 states
HighFDA (Food)·F-1575-2022·2022-08-31
Abbott Jevity Complete Enteral Nutrition Product Recalled for Potential Bottle Leaks
Abbott Laboratories is recalling Abbott Jevity Complete enteral nutrition products due to potential leaking or pinholes in the bottles. The recall affects 179 cases distributed to healthcare facilities in seven states.
Product
Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-1608-2022·2022-08-31
3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure
3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.
Product
3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1582-2022·2022-08-31
Homemade Bofrot/Puff Puff Mix Recalled for Undeclared Wheat Allergen
Pegroks Kitchen is recalling Homemade Bofrot/Puff Puff mix (24 oz packages) due to undeclared wheat allergen. Consumers with wheat allergies should not consume this product.
Product
Homemade Bofrot/Puff Puff mix, Pegroks Kitchen 24 ounce packages - 12 packages per case packaged in purple mylar bags
Category
Food
Distribution
2 states
HighFDA (Food)·F-1568-2022·2022-08-31
Enjoy Life Chewy Bars Recalled for Hard Plastic Contamination
Enjoy Life Natural Brands is recalling Chewy Bars - Caramel Blondie due to potential hard plastic pieces. About 89,736 cases were distributed in the US and Canada.
Product
Enjoy Life Chewy Bars Caramel Blondie (Chocolate Chip and Caramel), 5.75 oz (165g) UPC 819597011258 and 819597011333
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1568-2022·2022-08-31
Servo-air Ventilator Systems Lack Required Stability Warning Markings
Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.
Product
Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1586-2022·2022-08-31
ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure
Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.
Product
a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2022·2022-08-31
Medical Sponges Recalled for Temperature Exposure During Storage
Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.
Product
METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1606-2022·2022-08-31
Alere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage
Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Product
a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2022·2022-08-31
Medical Lubricating Jelly Recalled Due to Temperature Excursions During Storage
Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.
Product
FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2022·2022-08-31
Boston Scientific Guide Catheter Distributed With Wrong Tip Curve
Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.
Product
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1402-2022·2022-08-31
Petroleum Jelly Products Recalled for Improper Storage Conditions
Family Dollar Stores is recalling three petroleum jelly products (Swan, Baby Love, and Vaseline brands) distributed between April and June 2022 due to storage temperature deviations.
Product
SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU 910726 VASELINE PETROLEUM JELLY ORIGINAL 7.5 OZ 2099273 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1398-2022·2022-08-31
AZO YEAST PLUS 20 CT Recalled Due to Improper Storage Conditions
AZO YEAST PLUS 20 CT has been recalled by Family Dollar Stores due to improper storage temperature conditions that violate CGMP requirements. The product was distributed nationwide from April through June 2022.
Product
AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1584-2022·2022-08-31
Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2022·2022-08-31
Alcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit
Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.
Product
a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2022·2022-08-31
Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure
Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.
Product
Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1580-2022·2022-08-31
Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Risk
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier. The product was distributed nationwide and internationally.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1577-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1444-2022·2022-08-31
AFRIN No Drip Severe Congestion Recalled for Improper Storage Temperature
Family Dollar Stores is recalling AFRIN No Drip Severe Congestion 0.5 FL oz due to improper storage temperature conditions (CGMP deviation). The product was distributed to specific Family Dollar locations from April 30 through June 10, 2022.
Product
AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V660000·2022-08-31
2022 Nissan Rogue Fuel Tank May Leak Following Modifications
Certain 2022 Nissan Rogue vehicles have fuel tanks that may have been punctured during vehicle modifications, creating potential fuel leak and fire risk. Nissan will inspect and replace affected fuel tanks free of charge.
Product
NISSAN — NISSAN redundant ROGUE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2022·2022-08-31
MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
Product
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V655000·2022-08-30
Motorhomes with improperly routed hydraulic lines pose fire risk
REV is recalling 2018-2023 motorhome models from Fleetwood and Holiday Rambler because hydraulic lines may be improperly routed or protected, risking fluid leaks that could cause fires. Dealers will repair free of charge.
Product
HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VESTA, JAMBOREE, ADMIRAL, FLAIR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V656000·2022-08-30
Porsche Recalls Vehicles for Missing Headlight Adjustment Caps
Porsche is recalling 2001-2020 models because missing caps on headlight adjustment screws can cause improper alignment, increasing crash risk.
Product
PORSCHE — PORSCHE CAYENNE TRANSSYBERIA, CAYENNE, PANAMERA, BOXSTER S
Category
Vehicle
Distribution
Distributed nationwide