State

Alabama product recalls

73,096 recalls have nationwide distribution and so reach Alabama. 6,370 additional recalls listed Alabama specifically in their distribution scope.

What the numbers show

Total: 6,370
Critical: 1,131
Severe: 1,349
Most recent: 2026-09-23

Of the 6,370 recalls naming Alabama we have scored against our rubric, 1,131 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,349 (21%) are Severe.

Which agencies issued them

These figures cover only the 6,370 recalls whose distribution notice names Alabama specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9851–9875 of 79466

HighFDA (Devices)·Z-3212-2024·2024-10-02
Cervical disc replacement recalled for foreign contamination in assembly
Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3255-2024·2024-10-02
Biodesign Fistula Plug Implants Recalled Due to Premature Expiration
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Product
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3299-2024·2024-10-02
Arrow Arterial Kits Recalled Due to Open Packaging Seals
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.
Product
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2024·2024-10-02
Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3193-2024·2024-10-02
MRI Diagnostic Device Recalls Due to Loose Screw Assembly Risk
Philips recalls Evolution Upgrade 3.0T MRI devices due to loose screws that may block the tabletop and delay diagnosis. Devices with the affected serial numbers should be taken out of service.
Product
Evolution Upgrade 3.0T - 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) 782117 (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2024·2024-10-02
Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.
Product
Cath Lab Pack, CECL02P; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3285-2024·2024-10-02
Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- 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 (Drugs)·D-0666-2024·2024-10-02
Herbal Dietary Supplement Recalled for Undeclared Pharmaceuticals
Infla-650 Herbal Dietary Supplement is being recalled because it contains undeclared acetaminophen, diclofenac, and phenylbutazone. The product was marketed without FDA approval and poses a risk of drug interactions and adverse effects.
Product
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3200-2024·2024-10-02
MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Product
Ingenia Elition X- 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) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 78213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3233-2024·2024-10-02
Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization
American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.
Product
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
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-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-3240-2024·2024-10-02
Surgical convenience kit sterilization assurance cannot be confirmed
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Product
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3246-2024·2024-10-02
BD Phoenix M50 may misidentify E. coli bacteria in clinical samples
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
Product
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - 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: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3283-2024·2024-10-02
Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
Product
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- 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-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-3247-2024·2024-10-02
BD Phoenix diagnostic systems may misidentify E. coli in clinical samples
The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.
Product
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3199-2024·2024-10-02
MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment
Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.
Product
Ingenia Elition 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) 782150 2) 782106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3237-2024·2024-10-02
Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Product
Hand Pack, AKHD97C; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3293-2024·2024-10-02
Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
Product
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-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-3298-2024·2024-10-02
Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
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-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-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