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

11101–11125 of 13816

HighFDA (Devices)·Z-1834-2022·2022-10-05
Cook Guidewire Devices Recalled for Packaging Defect and Sterility Compromise
Cook Incorporated is recalling fixed core wire guide devices due to packaging defects that may compromise device sterility. Approximately 5,669 units were distributed in the US and 5,286 internationally.
Product
Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593
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
HighFDA (Devices)·Z-1840-2022·2022-10-05
Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.
Product
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2022·2022-10-05
Medical Guidewire Recalled for Packaging Defect Affecting Sterility
Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.
Product
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
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-1822-2022·2022-10-05
Humidifier Bottle and Syringe Filter Kit Sterile Barrier Breach Recall
CooperSurgical is recalling BT37 benchtop incubator humidifier and filter kits due to a potential sterile barrier breach. The defect may allow unsterilized devices to contaminate and degrade embryos during incubation.
Product
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1837-2022·2022-10-05
Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility
Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.
Product
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G175
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1828-2022·2022-10-05
Coons Interventional Guidewire Recall Due to Packaging Sterility Breach
Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.
Product
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
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-1812-2022·2022-10-05
t:slim X2 Insulin Pumps Recalled for Software Issues Affecting Blood Sugar Management
Tandem Diabetes Care is recalling approximately 8,399 t:slim X2 insulin pumps due to software malfunctions that may affect blood sugar control. A software update is available to resolve 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-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-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-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-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-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
ModerateFDA (Devices)·Z-1851-2022·2022-10-05
Leica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
Leica Microsystems is recalling 32 surgical operating microscopes due to a photodiode component defect that produces inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
Product
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1788-2022·2022-10-05
McKesson LiquiBand Exceed Skin Adhesive Storage Temperature Exposure Recall
McKesson is recalling LiquiBand Exceed skin adhesive products nationwide due to facility temperature excursions between June and August 2021. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip 2-Octyl Cyanoacrylate. Model Number: 122-LBXS. b. Skin Adhesive McKesson LiquiBand Exceed 0.8 mL Liquid Precision and Dome Applicator Tip 2-Octyl Cyanoacrylate. Ref: 122-LBX. c. ADVANCED MEDICAL SOLU
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1808-2022·2022-10-05
Petrolatum Jelly Recalled Due to Temperature Exposure Prior to Delivery
Petrolatum jelly products are being recalled because facility temperature excursions from June through August 2021 may have reduced product effectiveness. The FDA states this specific storage deviation is not likely to cause adverse health consequences.
Product
a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1140. b. DYNAREX Dynarex PETROLEUM JELLY, WHITE 4OZ TU(72/CS) DYNREX Catalog #1145
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1802-2022·2022-10-05
Medical Monofilament Testing Devices Recalled for Temperature Excursion
Mckesson Medical-Surgical is recalling monofilament sensory testing devices (13 units) due to temperature excursions during June-August 2021. Heat exposure may have compromised device effectiveness.
Product
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1806-2022·2022-10-05
McKesson Wound Dressing Products Recalled for Temperature Exposure
McKesson wound dressing products distributed nationwide are being recalled due to exposure to elevated temperatures during storage that may have reduced their effectiveness. No adverse health consequences have been reported.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2022·2022-10-05
Surgitube Surgical Bandages Recalled for Temperature Exposure During Storage
McKesson is recalling Surgitube surgical bandages distributed between June and September 2021 that may have been exposed to elevated temperatures during storage. The FDA states the temperature exposure is unlikely to cause adverse health effects.
Product
a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catalog #GL-219. b. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ2 1" 50YDS Catalog # GL-220. c. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ4 25/8" 50YDS Catalog # GL-222. d. D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1807-2022·2022-10-05
Wound Dressing Units Recalled Due to Storage Temperature Excursions
KerraCel Ag wound dressing units distributed between June and September 2021 are being recalled due to facility temperature excursions that may have affected product effectiveness. The FDA states no adverse health consequences are likely.
Product
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2022·2022-10-05
McKesson Calcium Alginate Wound Dressings Recalled for Temperature Exposure During Storage
McKesson Medical-Surgical is recalling multiple calcium alginate wound dressings due to facility temperature excursions that may have impacted product effectiveness. The FDA states the affected products are not likely to cause adverse health consequences.
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINA
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1817-2022·2022-10-05
Starling Monitor Devices Recalled for Incorrect Device Identification Labeling
Baxter Healthcare is recalling Starling Monitor devices and accessories due to incorrect Unique Device Identification (UDI) information on labels and non-compliant barcodes. Approximately 9,671 units distributed nationwide are affected.
Product
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1778-2022·2022-10-05
Incompatible tibial bearing supplied for knee prosthesis installation
An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.
Product
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Category
Medical Device
Distribution
0 states

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11101–11125 of 13816