State

California product recalls

73,100 recalls have nationwide distribution and so reach California. 13,251 additional recalls listed California specifically in their distribution scope.

What the numbers show

Total: 13,251
Critical: 1,605
Severe: 2,846
Most recent: 2026-09-25

Of the 13,251 recalls naming California we have scored against our rubric, 1,605 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,846 (21%) are Severe.

Which agencies issued them

These figures cover only the 13,251 recalls whose distribution notice names California specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10676–10700 of 86351

HighFDA (Devices)·Z-3259-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug units expire before labeled date
Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3251-2024·2024-10-02
Cook Biotech Fistula Plug recalled for expiring before labeled date
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Product
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3266-2024·2024-10-02
WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Product
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3203-2024·2024-10-02
MRI Diagnostic Device Screws May Loosen, Block Tabletop
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
Product
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3244-2024·2024-10-02
Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
Product
Pacemaker, COPM11B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3258-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3192-2024·2024-10-02
Biopsy instrument packaging holes compromise sterile barrier integrity
Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.
Product
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3197-2024·2024-10-02
MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop
Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.
Product
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3217-2024·2024-10-02
Siemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion
Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.
Product
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3275-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3269-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3281-2024·2024-10-02
Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3230-2024·2024-10-02
American Contract Systems Recalls Open Shoulder Medical Convenience Kits
American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.
Product
Open Shoulder, LWOS39L; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3288-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.
Product
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3202-2024·2024-10-02
Philips MR 7700 MRI Scanner Recall for Loose Screws
Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.
Product
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3224-2024·2024-10-02
Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.
Product
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3294-2024·2024-10-02
Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 units distributed worldwide.
Product
AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3301-2024·2024-10-02
Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.
Product
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3191-2024·2024-10-02
Custom Procedure Kit Sheath Introducers Mislabeled by Size
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Product
Custom Procedure Kit, REF: K12T-11077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3221-2024·2024-10-02
Medical endoscope recalled for unapproved sterilization instructions
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Product
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3220-2024·2024-10-02
Karl Storz Hopkins Telescope 6 endoscope recalled for unapproved reprocessing instructions
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
Product
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3225-2024·2024-10-02
Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0662-2024·2024-10-02
Sunscreen product recalled for microbial contamination nationwide
SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.
Product
SHEET SPF 30 MINERAL — SHEET SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3254-2024·2024-10-02
Cook Biotech Recalls Biodesign Fistula Plug Due to Early Expiration
Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.
Product
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3188-2024·2024-10-02
CooperSurgical Recalls Silver-Plated Copper Sims Uterine Sound for Incorrect Marking
CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.
Product
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Category
Medical Device
Distribution
Distributed nationwide