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.

19526–19550 of 50410

HighCPSC·21181·2021-08-18
Hallmark Teether Rings Recalled Due to Choking Hazard
Hallmark is recalling approximately 15,500 wooden teether rings with plush attachments because the wooden ring can break into small parts, creating a choking hazard. The company has received four reports of the rings breaking, including one case where a child placed broken pieces in their mouth.
Product
Teether Rings with Decorative Fabric and Plush Attachments
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2263-2021·2021-08-18
Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2021·2021-08-18
Hip Replacement Component Recalled for Potential Device Failure Risk
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2252-2021·2021-08-18
Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
Product
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2021·2021-08-18
Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Product
Spectrum Medical Quantum Standard heat exchanger
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2021·2021-08-18
Medline Knee Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
Product
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2021·2021-08-18
Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
Product
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2021·2021-08-18
Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion
Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0849-2021·2021-08-18
5000 Years Foods Kimchi Recalled for Listeria Contamination Risk
5000 Years Foods is recalling whole cabbage kimchi sold in plastic tubs and glass jars due to potential contamination with Listeria monocytogenes. The recalled product was distributed in Illinois and potentially nationwide through retail stores.
Product
5000 Years Foods WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2234-2021·2021-08-18
Medline Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.
Product
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21184·2021-08-18
TJX Recalls Swivel Counter Stools Due to Fall and Injury Hazards
TJX Companies is recalling about 4,300 swivel counter stools sold at HomeGoods and Homesense stores because they can break or collapse, causing falls. The company has received 20 reports of stools breaking, including 17 reports of minor injuries.
Product
Swivel Counter Stools
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2212-2021·2021-08-18
Medical device designed for healthcare professionals distributed to untrained home users
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2021·2021-08-18
Hip Implant Component Recalled for Fretting Corrosion Risk
Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2021·2021-08-18
Hospital Bed Model 3005 Recalled for Distribution to Home Residents
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2021·2021-08-18
Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities
Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.
Product
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2248-2021·2021-08-18
Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging
Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.
Product
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Set: Potential Internal Leak Risk
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2222-2021·2021-08-18
Stryker Electric Hospital Beds Recalled for Unintended Home Use
Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.
Product
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2239-2021·2021-08-18
Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling
Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-2268-2021·2021-08-18
Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion
Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2021·2021-08-18
Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities
Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.
Product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2021·2021-08-18
S3 MedSurg hospital beds recalled from residential sale due to misuse risk
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2276-2021·2021-08-18
Automated diagnostic analyzer from Abbott recalled for waste pressure buildup
Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.
Product
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2021·2021-08-18
Medical imaging software displays anatomical orientation tags incorrectly
Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.
Product
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2021·2021-08-18
Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities
Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.
Product
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Category
Medical Device
Distribution
Distributed nationwide