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.

19351–19375 of 50410

HighFDA (Devices)·Z-2396-2021·2021-09-08
Surgical alignment software error recalled in patient-specific orthopedic instruments
DePuy Orthopaedics recalls TruMatch surgical instruments due to a software error in the scanning alignment tool that may cause incorrect limb positioning during surgery.
Product
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number…
Category
Medical Device
Distribution
10 states
HighFDA (Food)·F-0947-2021·2021-09-08
Mai Cuisine Shrimp Tempura Kabuki Roll recalled for Salmonella
Mai Cuisine is recalling 12-piece Shrimp Tempura Kabuki Roll sold at Target Mai Sushi counters in Northern California because the frozen shrimp used in the product may be contaminated with Salmonella.
Product
12pc Shrimp Tempura Kabuki Roll WR UPC: 8 4003140626 2 Product was sold from Mai Sushi counters inside Target stores in Northern CA.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2389-2021·2021-09-08
Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure
Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.
Product
Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0945-2021·2021-09-08
WOK ST SHRIMP VEGGIE LO MEIN recalled for Salmonella contamination
Mai Cuisine is recalling WOK ST SHRIMP VEGGIE LO MEIN sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.
Product
WOK ST SHRIMP VEGGIE LO MEIN P UPC: 84003140247 Products were sold from Genji Sushi counters inside Whole Foods Market stores
Category
Food
Distribution
1 state
HighNHTSA·21C004000·2021-09-08
Dorel Maxi-Cosi Pria 70 Child Seat Recall for Tether Anchor Defect
Dorel Juvenile Group is recalling Maxi-Cosi Pria 70 convertible child seats because they may not adequately protect children from head injury in a crash if installed without a top tether.
Product
CHILD SEAT:VEHICLE TETHER ANCHOR recall
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0950-2021·2021-09-08
Chef's Assorted Nigiri 6PC recalled for Salmonella contamination
Mai Cuisine is recalling Chef's Assorted Nigiri 6PC sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the sushi products.
Product
CHEF'S ASSORTED NIGIRI 6PC UPC: 81282401130 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0942-2021·2021-09-08
Spicy Shrimp Inari Sushi recalled for Salmonella contamination
Mai Cuisine is recalling Spicy Shrimp Inari 4 PC sushi products sold at Whole Foods Market Genji Sushi counters in Northern California due to Salmonella contamination in the frozen shrimp ingredient.
Product
Spicy Shrimp Inari 4 PC [WR] UPC: 81244803399 Products were sold from Genji Sushi counters inside Whole Foods Market stores
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2379-2021·2021-09-08
Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure
Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.
Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0938-2021·2021-09-08
Shrimp California Roll Recall Due to Salmonella Contamination
Mai Cuisine is recalling Shrimp California Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.
Product
Shrimp California Roll [BR] UPC: 81244803702 Products were sold from Genji Sushi counters inside Whole Foods Market stores
Category
Food
Distribution
1 state
HighFDA (Food)·F-0940-2021·2021-09-08
Shrimp Summer Roll Recall Due to Salmonella Contamination
Mai Cuisine is recalling Shrimp Summer Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used to make the sushi products.
Product
Shrimp Summer Roll UPC:81282401393 Products were sold from Genji Sushi counters inside Whole Foods Market stores
Category
Food
Distribution
1 state
HighNHTSA·21V696000·2021-09-08
Blue Bird Recalls 2022 Vision School Buses for Camera Obstruction
Blue Bird is recalling 2022 Vision school buses because the collision mitigation camera may block the driver's view of the passenger side cross-view mirror, increasing pedestrian injury risk.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0936-2021·2021-09-08
Rainbow Sushi Set recalled due to Salmonella in frozen shrimp
Mai Cuisine's Rainbow Sushi Set sold at Whole Foods Market Genji Sushi counters in Northern California is being recalled because frozen shrimp used in the product was contaminated with Salmonella.
Product
Rainbow Sushi Set [WR] UPC:81244803418 Products were sold from Genji Sushi counters inside Whole Foods Market stores
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2397-2021·2021-09-08
TruMatch Surgical Instruments Recalled for Software Alignment Error
DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.
Product
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part…
Category
Medical Device
Distribution
10 states
HighFDA (Food)·F-0949-2021·2021-09-08
Mai Cuisine Sushi Sets Recalled for Salmonella in Shrimp
Mai Cuisine is recalling Special Roll Super Set 16-piece sushi products sold at New Leaf Community Market locations in Northern California due to Salmonella contamination in frozen shrimp used in the products.
Product
SPECIAL ROLL SUPER SET 16PC UPC: 81282401129 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2384-2021·2021-09-08
MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0954-2021·2021-09-08
Mai Cuisine Shrimp Mango Fresh Rolls recalled for Salmonella contamination
Mai Cuisine is recalling Shrimp Mango Fresh Rolls sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in the frozen shrimp used in the product.
Product
SHRIMP MANGO FRESH ROLL UPC:81282401374 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2387-2021·2021-09-08
Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue
Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.
Product
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2382-2021·2021-09-08
FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0903-2021·2021-09-08
Strawberry Yogurt Granola Parfait Recalled for Undeclared Soy
Loffredo Fresh Gardens Inc. is recalling Strawberry Yogurt Granola Parfait products sold under multiple brands because soy lecithin in the yogurt ingredient is not declared on the label, posing a risk to consumers with soy allergies.
Product
Strawberry Yogurt Granola Parfait packaged in clear plastic cups and labeled in the following ways: 1) Go Fresh Market Strawberry Granola Yogurt, Net wt. 6.5 oz (184 g), UPC 7 58870 32670 5, Distributed by Produce Innovation, Norwalk, IA; 2) HWY 28 Farms, Strawberry Yogurt…
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-2383-2021·2021-09-08
CoolSculpting Elite System Software Error May Misreport Thermal Events
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-2380-2021·2021-09-08
Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns
Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.
Product
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2021·2021-09-08
Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
Product
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2405-2021·2021-09-08
Discectomy Device Kit Class II recall due to sterile barrier compromise
Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.
Product
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2409-2021·2021-09-08
Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution
Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2388-2021·2021-09-08
Surgical arm suspension kits recalled due to sterilization concerns
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.
Product
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Category
Medical Device
Distribution
Distributed nationwide