Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9301–9325 of 27393

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-1826-2022·2022-10-05
Bentson Wire Guide Devices Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.
Product
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
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 (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-1786-2022·2022-10-05
Mobile X-Ray System Recalled for Software Calibration Error in Radiation Dose Meter
Micro-X Rover mobile X-ray systems recalled due to a software calibration error that causes incorrect radiation dose readings. The malfunction may impede proper radiation exposure management decisions.
Product
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
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 Schuma
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1836-2022·2022-10-05
Cook Newton Wire Guide Recalls Due to Potential Sterility Compromise
Cook Incorporated is recalling certain Newton Wire Guide surgical guidewires because packaging seals may be breached, potentially compromising device sterility.
Product
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
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
HighFDA (Devices)·Z-1785-2022·2022-10-05
BD Pyxis MedBank Cabinet Software Update Prevents Drawer Access
A software update for BD Pyxis MedBank medication dispensing cabinets contains an incompatible file that prevents Matrix drawers from opening, potentially delaying medication access in healthcare facilities.
Product
BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 . MedBank 200 Main operating with Windows 7 . MedBank 500 Main operating with Windows 7. An automated dispensing cabinet intende
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2022·2022-10-05
Cook guidewires recalled for compromised sterility due to packaging breach
Cook Incorporated is recalling Amplatz extra Stiff Wire Guides because packaging seals may be completely breached, potentially compromising device sterility.
Product
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2022·2022-10-05
VIDAS CMV IgM diagnostic test kits recalled for invalid calibrations
bioMerieux is recalling 480 VIDAS CMV IgM test kits with invalid calibrations distributed across 18 U.S. states. The calibration errors may affect diagnostic test accuracy.
Product
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1761-2022·2022-10-05
NanoSight particle analyzer recalled for laser safety non-compliance
Malvern Panalytical is recalling approximately 111 NanoSight LM10 instruments with LM12 modules nationwide due to non-compliance with Class I laser safety requirements. Users may be exposed to unsafe laser radiation.
Product
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1843-2022·2022-10-05
Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect
Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.
Product
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2022·2022-10-05
Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal
Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.
Product
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2022·2022-10-05
Siemens Magnesium Test Cartridges May Produce Erroneous Results Without Alert
Siemens Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering warning flags. Some results may show magnesium levels 15–59% lower than actual values.
Product
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
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 (Devices)·Z-1819-2022·2022-10-05
VenaCure EVLT procedure kit fiber component fails dimensional specification
Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.
Product
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2022·2022-10-05
Medline ClearPro Suction Catheter Connector May Separate During Use
Medline ClearPro closed suction catheters may have a connector that separates from the device during patient suctioning. The malfunction affects 65,320 units distributed nationwide and internationally.
Product
MEDLINE CLEARPRO 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. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2022·2022-10-05
Barco Medical Network Adapter Recalled for Installation Issues
Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.
Product
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1849-2022·2022-10-05
Leica Surgical Operating Microscopes recalled for illumination adjustment defect
Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
Product
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1814-2022·2022-10-05
Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction
Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying treatment.
Product
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
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-1830-2022·2022-10-05
Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach
Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.
Product
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1838-2022·2022-10-05
FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach
Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.
Product
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
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

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9301–9325 of 27393