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.

36351–36375 of 50504

HighFDA (Food)·F-0751-2016·2016-03-23
Casper's Sea Salt Caramel Pretzel Ice Cream Recalled for Allergen Mislabeling
Casper's Ice Cream is recalling Sea Salt Caramel Pretzel Ice Cream because it contains Caramel Cashew ice cream, presenting a potential allergen threat.
Product
Sea Salt Caramel Pretzel Ice Cream, Red Button Vintage Creamery, 56 fluid ounce, Paper Tub, 6 tubs per case, Distributed by Associated Foods, Inc. Utah; Manufactured by Caspers Ice Cream, Inc. Utah
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-1185-2016·2016-03-23
Stryker Recalls 36 Non-Powered Stretchers Due to Hydraulic Jack Assembly Defect
Stryker is recalling 36 non-powered stretchers because hydraulic jack assemblies were manufactured with incorrect oil, increasing the risk of leaks or jack drift.
Product
Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1148-2016·2016-03-23
Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0750-2016·2016-03-23
Dawn's Potato Salad Recalled for Undeclared Allergens
Dawn's Foods is recalling Deluxe and Deviled Egg Potato Salad due to mislabeling and potential undeclared milk, wheat, and soy.
Product
Dawn's Deluxe Potato Salad, Net Wt. 15 oz. (425g), UPC 32345-10015. Keep Refrigerated.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1161-2016·2016-03-23
Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.
Product
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2016·2016-03-23
Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns
Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.
Product
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V166000·2016-03-23
Bugatti Recalls Veyron Models Due to Corroding Underbody Aluminum Plates
Bugatti is recalling 2006-2013 Veyron models because underbody aluminum plates may corrode and detach, posing a road hazard to other vehicles.
Product
BUGATTI — BUGATTI VEYRON, VEYRON GRAND SPORT, VEYRON SUPER SPORT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0756-2016·2016-03-23
NatureBox Cinnamon Yogurt Mini Grahams Recalled for Allergen Mislabeling
NatureBox is recalling Cinnamon Yogurt Mini Grahams because some bags were packaged in Probiotic Power Mix bags that fail to declare wheat as an allergen.
Product
NatureBox Cinnamon Yogurt Mini Grahams, 6 oz. (170g) customer stand up pouches. UPC 8 58590 00528 4 Ingredients: Graham Crackers (unbleached unenriched wheat flour, whole wheat graham flour, sugar, palm and palm kernel oil, molasses, honey, salt, sodium bicarbonate).…
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1100-2016·2016-03-23
Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
Product
Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2016·2016-03-23
CareFusion Recalls Alaris VersaSafe Infusion Sets Due to Leakage
CareFusion is recalling 5,760 Alaris VersaSafe Infusion Sets distributed in Michigan because the split septum port may separate or leak.
Product
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1126-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.
Product
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1172-2016·2016-03-23
Roche Recalls Accu-Chek Inform II Base Units Due to Data Loss Risk
Roche is recalling Accu-Chek Inform II Base Units because they may lose data or mismatch patient records when connected to specific Data Management Systems.
Product
Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1137-2016·2016-03-23
Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.
Product
Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2016·2016-03-23
Pro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers
Pro-Dex Inc is recalling sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.
Product
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1176-2016·2016-03-23
CHG Hospital Beds Recalls Spirit Select Beds Due to Alarm Defect
CHG Hospital Beds is recalling 1,892 Spirit Select beds because the bed exit alarm may fail to function, potentially delaying assistance after a patient fall.
Product
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1174-2016·2016-03-23
Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size
Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.
Product
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2016·2016-03-23
Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.
Product
Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2016·2016-03-23
McKesson Medical Imaging Software Recalled for Potential Image Display Errors
McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.
Product
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1150-2016·2016-03-23
Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.
Product
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2016·2016-03-23
Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues
Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2016·2016-03-23
Deerfield Imaging Recalls Intraoperative MRI Systems Due to Venting Line Defect
Deerfield Imaging is recalling specific intraoperative MRI systems because emergency helium venting lines may not have been properly installed.
Product
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1110-2016·2016-03-23
Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.
Product
Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2016·2016-03-23
Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
Product
Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1163-2016·2016-03-23
Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns
Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.
Product
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006…
Category
Medical Device
Distribution
Distributed nationwide