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

10976–11000 of 13748

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-1810-2022·2022-10-05
Insulin Infusion Sets Recalled for Incorrect Dosing Information in Instructions
Autosoft 90 insulin infusion sets are recalled because the instructions incorrectly state insulin fill values for two cannula sizes, potentially causing patients to receive fewer insulin units than intended.
Product
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1842-2022·2022-10-05
Cook Rosen Curved Wire Guide Recall: Sterility Concerns
Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.
Product
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1841-2022·2022-10-05
Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise
Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.
Product
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
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-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-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 Number/REF:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1829-2022·2022-10-05
Cope Nitinol Guidewire Recalled Due to Packaging Sterility Breach
Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.
Product
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
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-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-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-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-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-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-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-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-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-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-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-1762-2022·2022-10-05
Laboratory Instrument Recalled for Class 1 Laser Safety Non-Compliance
Malvern Panalytical is recalling 76 NanoSight LM10 laboratory instruments that do not comply with Class 1 laser safety requirements. The company is taking this action to prevent potential laser exposure risks.
Product
NanoSight LM10 fitted with LM14 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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

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10976–11000 of 13748