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.

15776–15800 of 53092

HighFDA (Devices)·Z-1857-2022·2022-10-05
Medline ClearPro Trach T-Piece Suction Catheter May Separate at Connector
Medline is recalling 136,080 ClearPro Trach T-Piece Closed Suction Catheters because the suction catheter can come apart from the connector during patient suctioning.
Product
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1777-2022·2022-10-05
Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.
Product
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1823-2022·2022-10-05
CooperSurgical incubator humidifier kit recall due to sterile barrier breach
CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1827-2022·2022-10-05
Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility
Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.
Product
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2022·2022-10-05
Medline suction catheters recalled due to connector separation risk
Medline ClearPro Trach Double Swivel Closed Suction Catheters may have the green connector separate from the device during patient suctioning. The recall affects 34,920 units distributed nationwide and internationally.
Product
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2022·2022-10-05
Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal
Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.
Product
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1846-2022·2022-10-05
Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect
Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.
Product
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2022·2022-10-05
SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles
SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.
Product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Category
Medical Device
Distribution
10 states
HighFDA (Food)·F-1807-2022·2022-10-05
Frozen Organic Hash Browns Recalled for Listeria Contamination Risk
Sprouts and True Goodness frozen organic hash browns are being recalled due to potential Listeria monocytogenes contamination. Products were distributed nationwide and internationally.
Product
Item SP204, Sprouts Organic Hash Browns Shredded Potatoes, 16 oz. bag, 12/16 oz. bags per case. Product contains Organic Potatoes and is frozen and it's not ready to eat and labeled with cooking instructions. Manufactured For Sprouts Farmers Market Phoenix, Arizona 85054. UPC…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2022·2022-10-05
Vinyl Connecting Tubes Recalled Due to Packaging Seal Breach
Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which may compromise device sterility.
Product
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2022·2022-10-05
Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.
Product
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1850-2022·2022-10-05
Leica M530 Surgical Microscopes recalled for illumination adjustment defect
Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.
Product
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1852-2022·2022-10-05
YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall
Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.
Product
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1853-2022·2022-10-05
YelloPort Plus 5x70 Cannula recalled: labeled sterile but non-sterile
YelloPort Plus 5x70 Cannula devices are labeled as sterile but are actually non-sterile. This mislabeling poses an infection risk for laparoscopic surgical patients.
Product
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1820-2022·2022-10-05
Siemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results
Siemens is recalling IMMULITE 2000 and XPi Thyroid Stimulating Immunoglobulins test kits due to a -23% negative bias that may produce falsely low results, potentially delaying diagnosis of autoimmune thyroid disease.
Product
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1835-2022·2022-10-05
Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach
Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.
Product
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2022·2022-10-05
Cook Medical Guidewire Recall: Packaging Seal Breach May Compromise Sterility
Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.
Product
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1832-2022·2022-10-05
Cook Guidewire Products Recalled Due to Compromised Sterile Packaging
Cook Incorporated is recalling Fixed Core Wire Guide products due to potential breach of sterile packaging seals. Affected devices may have compromised sterility.
Product
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V742000·2022-10-05
Audi vehicles recalled for faulty rearview camera display software
Certain 2021-2022 Audi vehicles may display a blank or black screen instead of the rearview camera image in reverse, reducing rear visibility and increasing crash risk. Dealers will update the infotainment software at no cost.
Product
AUDI — AUDI A5 CABRIOLET, SQ8, S5, E-TRON GT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1845-2022·2022-10-05
Cook Lunderquist Ring Torque Wire Guide packaging breach may compromise sterility
Cook Incorporated is recalling Lunderquist Ring Torque Wire Guides due to a complete breach in the chevron seal of the packaging, which may compromise device sterility. The recall affects multiple lot numbers distributed nationwide and internationally.
Product
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2022·2022-10-05
OSSUR Power Knee Prosthetics Recalled for Battery Dislodgement Risk
OSSUR Power Knee prosthetics are being recalled because the battery may dislodge from the device. Approximately 190 units are affected across the United States.
Product
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1544-2022·2022-10-05
Oxytocin injection recalled for incorrect sodium chloride concentration
QuVa Pharma is recalling oxytocin injections due to incorrect formulation. Bags contain 0.45% sodium chloride instead of the intended 0.9%.
Product
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1818-2022·2022-10-05
Diagnostic imaging software may lose patient information edits during processing
Ambra PACS and ProViewer versions 3.22.2.0 and 3.22.3.0 have a software defect where patient information edits may be lost during initial study processing due to a race condition between database systems.
Product
Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-1813-2022·2022-10-05
Olympus POWERSEAL surgical sealer recalled for loose retention ring defect
Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.
Product
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2022·2022-10-05
Insulin pumps recalled for software malfunctions affecting blood glucose control
Tandem Diabetes Care is recalling 31,100 t:slim X2 insulin pumps due to software issues that could cause inaccurate insulin delivery, potentially leading to dangerous blood sugar levels. A software update is available to address the issues.
Product
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Category
Medical Device
Distribution
53 states